Needle assembly and fluid delivery system with needle assembly

Abstract

One or more needle assemblies for a fluid delivery device includes a needle support that includes a connector coupler having various manufacturing methods to form a leak-tight seal around the needle. A flexible connector has a connector bore forming a fluid path in fluid communication with a bore of the needle. A driven member is disposed at least partially in the housing and driven to move the needle support(s) to move between a compact configuration, in which fluid may not be transferred through the needle, and an extended configuration, in which fluid may be transferred through the needle. A movable carousel can move the selected needle assembly of many to the activated position for fluid or drug delivery.

Description

NEEDLE ASSEMBLY AND FLUID DELIVERY SYSTEM WITH NEEDLE ASSEMBLYFIELD OF THE DISCLOSURE

[0001] The present disclosure relates generally to fluid delivery devices, such as injection devices. More specifically, the present disclosure relates to a needle assemblies of fluid delivery devices.BACKGROUND OF THE DISCLOSURE

[0002] Conventional injection devices are often used to inject a medication fluid into a patient via a needle. It is sometimes advantageous for the medication to be administered without the presence of a medical professional, such as when the medication is to be administered frequently (e.g., daily at different times during each day). However, it may be a challenge to ensure that needles are maintained in a sterile environment prior to use in injections, as well to ensure that the medication is administered safely, efficiently, and in a proper amount. Furthermore, some patients are uncomfortable with seeing or directly handling needles.SUMMARY

[0003] In a first aspect of the disclosure, a needle assembly is disclosed. The needle assembly includes a housing and a needle. A needle support is disposed in the housing and includes a connector coupler molded around the needle to form a leak-tight seal around the needle. A flexible connector is disposed in the housing and has a connector bore forming a fluid path in fluid communication with a bore of the needle. The connector includes a first end portion attached to the connector coupler. A driven member is disposed at least partially in the housing and configured to be driven to move the needle support to move to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle. A non-piercing end portion of the needle extends beyond the connector coupler and is disposed in the connectorbore, and a piercing end portion of the needle extends beyond the connector coupler. In the compact configuration, the connector is curved in a loop or a partial loop and the needle is disposed in the housing. In the extended configuration, the connector has an elongated shape and at least some of the piercing end portion of the needle extends beyond the housing, and the connector bore at the first end of the connector is parallel to or coaxial with the connector bore at a second end of the connector.

[0004] In a second aspect of the disclosure, a needle system having a housing, a movable carousel disposed at least partially in the housing, and a plurality of selectable needle assemblies mounted on the carousel is disclosed. The needle assemblies are disposed at least partially in the housing. Each of the needle assemblies includes a needle, a needle support having a connector coupler molded around the needle to form a leak-tight seal around the needle, and a flexible connector having a connector bore forming a fluid path in fluid communication with a bore of the needle. The connector includes a first end portion attached to the connector coupler. A driven member is configured to be driven to move the needle support to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle. The needle driver is configured to engage with a selected needle assembly of the selectable needle assemblies when the selected needle assembly is in an activated position, to move the needle support of the selected needle assembly to and from a compact configuration and an extended configuration. The movable carousel is configured to move the selected needle assembly to the activated position.

[0005] In a third aspect of the disclosure, a method of manufacturing a needle assembly is disclosed. The method includes one or more of the following steps. Molding a needle support around a needle such that a connector coupler of the needle support surrounds a section of the needle and forms a leak -tight seal around the section of the needle, a non-piercing end of the needle extending beyond the connector coupler. Inserting a portion of the connector coupler intoa bore of a resilient and flexible connector such that the non-piercing end of the needle is disposed in the bore of the connector.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Various aspects, techniques, and embodiments of the present technology disclosed herein are described below with reference to the accompanying drawings. It should be appreciated that the figures are not necessarily drawn to scale. Items appearing in multiple figures may be indicated by the same reference numeral. For purposes of clarity, not every component may be labeled in every figure. Features of the present technology will become more apparent, and techniques for how to attain the features of the present technology, will be better understood by reference to the following detailed description considered in conjunction with the accompanying drawings, wherein:

[0007] FIG. 1 shows a perspective view of a dispenser comprising a cartridge assembly and a needle system.

[0008] FIG. 2 shows a perspective view of the cartridge assembly of FIG. 1.

[0009] FIG. 3 shows a perspective view of the cartridge assembly of FIG. 1 in a partially disassembled state.

[0010] FIG. 4A shows a perspective view of a longitudinal cross-section of the cartridge assembly of FIG. 1.

[0011] FIG. 4B shows another perspective view of a longitudinal cross-section of the cartridge assembly of FIG. 1.

[0012] FIG. 4C shows a perspective view of cross-section of the cartridge assembly of FIG.1 cut along a plane 4C in FIG. 4A.

[0013] FIG. 4D shows a plan view of a slice of the cartridge assembly of FIG. 1 cut along parallel planes 4D in FIG. 4A.

[0014] FIG. 4E shows a plan view of a proximal end of the cartridge assembly of FIG. 1.

[0015] FIG. 4F shows a perspective view of a proximal end of a foot of a cartridge assembly.

[0016] FIG. 4G shows a perspective view of a ribbon and a bearing configured to engage with the foot of FIG. 4F.

[0017] FIG. 5 schematically shows an plan view of a longitudinal cross-section of a portion of a proximal end of a first variation 5A and a second variation 5B of the cartridge assembly of FIG. 1.

[0018] FIGs. 6A and 6B show elevational side views of an axially extendible ribbon. In FIGs. 6A and 6B, a distal end of the ribbon is on the left and a proximal end of the ribbon is on the right. In FIGs. 6A and 6B, the ribbon is in an unstressed state and has a configuration of a tapered helix.

[0019] FIG. 6C shows an elevational end view of the axially extendible ribbon of FIG. 6A in the unstressed state. In FIG. 6C, an external surface of the distal end of the ribbon is shown.

[0020] FIG. 6D shows an elevational end view of the axially extendible ribbon of FIG. 6A in the unstressed state. In FIG. 6D, an internal surface of the distal end of the ribbon is shown.

[0021] FIG. 7A shows a perspective view of a cartridge assembly and a driver gear configured to rotationally drive a portion of the cartridge assembly.

[0022] FIG. 7B shows another perspective view of the cartridge assembly and the driver gear of FIG. 7 A.

[0023] FIG. 7C shows a perspective view of the driver gear of FIG. 7A.

[0024] FIG. 8 shows a perspective view of a dispenser comprising a cartridge assembly and a needle assembly.

[0025] FIG. 9A shows a perspective view of the needle assembly of FIG. 8.

[0026] FIG. 9B shows a plan view of a cross-section of the needle assembly of FIG. 9 A cut along a plane 9B in FIG. 9A. In FIG. 9B, a surface on the left of the plane 9B is shown.

[0027] FIG. 9C shows a perspective view of the needle assembly of FIG. 9A in a partially disassembled state.

[0028] FIG. 10 shows a perspective view of a cassette comprising a dispenser partially inserted in a cassette housing. In FIG. 10, driver gears for driving movement in the dispenser are shown.

[0029] FIGs. 11 A and 1 IB show a perspective view of a partial longitudinal cross-section of a needle assembly partially inserted and fully inserted, respectively, in a cassette housing. In FIG. 11 A, a gear lock of the needle assembly is in a locked state. In FIG. 1 IB, the gear lock is in an unlocked state.

[0030] FIG. 12A shows a perspective view of a distal section of a dispenser.

[0031] FIG. 12B shows the same view as FIG. 12A but with a housing of a needle assembly of the dispenser appearing translucent.

[0032] FIG. 12C shows a perspective view of the distal section of the dispenser of FIG. 12B in a partially disassembled state.

[0033] FIGs. 13A and 13B show plan views of a longitudinal cross-section of a needle assembly in a locked state and an unlocked state, respectively. In FIG. 13 A, a transfer gear (idler) is prevented from rotating a needle-movement gear of the needle assembly by a spring pushing a lock plate against a housing protrusion. In FIG. 13B, the transfer gear (idler) and the needle-movement gear are in an engaged state, with the transfer gear (idler) being spaced apart from the housing protrusion and therefore not prevented from rotating the needle-movement gear.

[0034] FIG. 13C shows a plan view of a lateral cross-section of the needle assembly of FIG. 13A cut through the lock plate, showing portions of the lock plate blocking rotational movement of a needle selector.

[0035] FIG. 13D shows a plan view of a lateral cross-section of the needle assembly of FIG. 13A cut through the transfer gear (idler), showing lips comprising the housing protrusion blocking rotational movement of the transfer gear.

[0036] FIG. 14A shows an elevational side view of a distal section of a cassette.

[0037] FIG. 14B shows a perspective view of the distal end of the cassette of FIG. 14A. In FIG. 14B, a latch of a housing of the cassette is latched to a dispenser of the cassette, preventing the dispenser from moving relative to the housing.

[0038] FIG. 14C shows a perspective view of the distal end of FIG. 14B. In FIG. 14C, the latch is unlatched from the dispenser, enabling a biased spring of a gear lock of the dispenser to move the dispenser outwards relative to the housing of the cassette.

[0039] FIG. 14D shows a perspective view of the distal end of FIG. 14C. In FIG. 14D, after being unlatched, the dispenser is movable out of the housing of the cassette and a new dispenser is movable into the housing the cassette.

[0040] FIG. 15A shows a plan view of a longitudinal cross-section of a distal end of a cassette. In FIG. 15A, a latch of a housing of the cassette is latched to a latch receiver of a dispenser of the cassette, preventing the dispenser from moving relative to the housing.

[0041] FIG. 15B shows a plan view of a longitudinal cross-section of the distal end of FIG.15A. In FIG. 15B, the latch of the housing of the cassette is unlatched from the latch receiver of the dispenser, enabling a biased spring of a gear lock of the dispenser to move the dispenser outwards relative to the housing.

[0042] FIG. 15C shows a plan view of a longitudinal cross-section of the distal end of FIG. 15B. In FIG. 15C, after being unlatched, the dispenser is movable out of the housing of the cassette and a new dispenser is movable into the housing.

[0043] FIG. 16A shows an elevational side view of a distal section of a cassette.

[0044] FIG. 16B shows a perspective view of the distal end of the cassette of FIG. 16A. InFIG. 16B, a latch-release actuator of the cassette is in a hold position preventing a dispenser from moving relative to a housing of the cassette.

[0045] FIG. 16C shows a perspective view of the distal end of FIG. 16B. In FIG. 16C, the latch-release actuator is moved to a release position by a lateral force, which enables a latch to pivot to disengage from an engagement surface of the dispenser, and which in turn enables a biased spring of a gear lock of the dispenser to move the dispenser outwards relative to the housing.

[0046] FIG. 16D shows a perspective view of the distal end of FIG. 16C. In FIG. 14D, after being disengaged, the dispenser is movable out of the housing of the cassette and a new dispenser is movable into the housing the cassette.

[0047] FIG. 17A shows a plan view of a longitudinal cross-section of a distal end of a cassette. In FIG. 17A, a latch of a housing of the cassette is latched to an engagement surface protruding from a dispenser of the cassette, preventing the dispenser from moving relative to the housing.

[0048] FIG. 17B shows a plan view of a longitudinal cross-section of the distal end of FIG.15 A. In FIG. 17B, the latch of the housing of the cassette is pivoted by an actuator to disengage from the engagement surface protruding from the dispenser, enabling a biased spring of a gear lock of the dispenser to move the dispenser relative to the housing of the cassette.

[0049] FIG. 17C shows a plan view of a longitudinal cross-section of the distal end of FIG.17B. In FIG. 17C, after being disengaged, the dispenser is movable out of the housing of the cassette and a new dispenser is movable into the housing.

[0050] FIGs. 18A and 18B show, respectively, a perspective view of a cassette housing during insertion of a dispenser into the cassette housing and a perspective view of the dispenser fully inserted in the cassette housing. In FIGs. 18A and 18B, a driver gear for rotating a needleselection gear of the dispenser is positioned at an opening through which the driver gear rotates the needle-selectin gear.

[0051] FIG. 18C shows an enlarged perspective view of a compartment of the cassette housing of FIG. 18B. In FIG. 18C, a needle assembly of the dispenser is fully inserted the compartment and the driver gear is not shown at the opening, such that a portion of the needleselection gear is visible through the opening. Although not fully visible in FIG. 18C, a portion of another opening is shown, through which another driver gear may rotate a needle-movement gear of the dispenser (e g., via a transfer gear).

[0052] FIG. 19 shows a block diagram of a motor assembly comprising a plurality of driver assemblies and a controller for controlling the driver assemblies.

[0053] FIG. 20A shows a perspective view of a cassette comprising a dispenser fully inserted in a housing of the cassette. In FIG. 20A, a driver gear is engaged with a drive assembly of the dispenser, and a cartridge of the dispenser is aligned with and visible through a window of the housing.

[0054] FIG. 20B shows a perspective view of the cassette of FIG. 20A while the dispenser is being inserted in the housing.

[0055] FIG. 21 shows a block diagram of a medication delivery device including a cassette, a motor assembly, and a controller.

[0056] FIG. 22A shows a perspective view of a proximal end of a needle system mounted to a cartridge assembly.

[0057] FIG. 22B shows a perspective view of a distal end of the needle system of FIG. 22A with only a housing of the cartridge assembly shown.

[0058] FIG. 22C shows a perspective view of the proximal end of the needle system of FIG.22A, without showing a housing of the needle assembly.

[0059] FIG. 22D shows a perspective view of the distal end of the needle system of FIG.22C, without showing an identification ring.

[0060] FIG. 22E shows a perspective view of an internal portion of the needle system of FIG. 22A.

[0061] FIG. 22F shows a perspective view of the needle system of FIG. 22A with a portion of the housing of the needle system appearing translucent.

[0062] FIG. 22G shows a perspective view of the distal end of the needle system of FIG.22A.

[0063] FIG. 23 A shows a perspective view of the proximal end of the needle system of FIG.22B, showing an opening through which an indexing gear of the needle system is exposed.

[0064] FIG. 23B shows a perspective view of a proximal end of the indexing gear.

[0065] FIG. 23 C shows a stabilizer portion relative to teeth of the indexing gear when a needle assembly is in an activated position of the needle system.

[0066] FIG. 24A shows a longitudinal cross section of the needle system.

[0067] FIG. 24B shows an enlarged cross section of a portion of the needle system.

[0068] FIG. 25 shows a perspective view of a needle assembly of the needle system.

[0069] FIG. 26A shows a side perspective view of the needle system, showing an access opening for engaging with a needle assembly in the activated position.

[0070] FIG. 26B shows a needle driver of the needle system, for driving movement of portions of a needle assembly in the activated position.

[0071] FIG. 26C shows an external driver extending through the housing of the needle system, for rotating the needle driver.

[0072] FIG. 27A shows a side plan view of a needle assembly with a translucent housing.

[0073] FIG. 27B shows a perspective view of a needle system incorporating the needle assembly of FIG. 27A.

[0074] FIG. 28 shows a perspective view of a needle assembly showing a needle mechanism.

[0075] FIGs. 29A and 29B show perspective views of a needle mechanism, depicting opposite sides of the needle mechanism.

[0076] FIGs. 30A and 30B show perspective views of a driven member of a needle system, depicting opposite sides of the driven member.

[0077] FIG. 31 A shows a side view of the needle mechanisms of FIG. 30A in a compact configuration.

[0078] FIG. 3 IB shows a side view of the needle mechanism of FIG. 30B in an extended configuration.

[0079] FIGs. 32A, 32B, and 32C show views of a needle mechanism in a compact standby configuration before use, an extended configuration during use, and a compact retracted configuration after use, respectively.

[0080] FIG. 33 shows a side view of the needle mechanism in the needle assembly in the retracted configuration, after use.

[0081] FIG. 34 shows a cross-sectional side view of a needle mechanism disposed in a housing, with the needle mechanism being in an extended configuration.

[0082] FIG. 35 shows a longitudinal cross section of a portion of a needle mechanism.

[0083] FIGs. 36A through 36E show various arrangements for coupling a needle to a needle connector of a needle mechanism.DETAILED DESCRIPTION

[0084] Provided herein are examples of fluid delivery devices, as well as examples of components included in the fluid delivery devices. As will be appreciated, although some examples of the fluid delivery devices are described herein in connection with administering a medication to a patient, such devices are not limited to use in medical applications and may additionally or alternatively be used in other non-medical applications (e.g., where a precise amount of fluid is to be delivered).

[0085] The inventors have recognized and appreciated that various factors can be important for fluid delivery devices. In particular, while ease of use of a fluid delivery device can be important, minimizing medical waste may also be important. The fluid delivery devices provided herein may enable multiple needles to be provided and individually activated to deliver multiple doses of medication from a single vial or fluid chamber, thus reducing waste associated with multiple needle packages and / or multiple single-dose vials of medication. The multiple doses may be injected at different times using different ones of the needles or the doses may be injected at different times using a single one of the needles. For example, a patient may use one needle for multiple injections for one day, and may use another needle for multiple injections for another day. hr some embodiments, single needle configurations can also be used according to the techniques described herein.

[0086] Turning now to the figures, FIG. 1 shows a perspective view of a dispenser 10 comprising a cartridge assembly 100 and a needle system 200, according to some embodiments of the present technology. The dispenser 10 may be used in a fluid delivery cassette, as discussed below. The needle system 200 may be located at a distal end of the dispenser 10. For the sake of clarity, the term “distal” may be used herein to identify a location closer to an outlet of a needle of the needle system (e.g., closer to an end that comes into contact with a patient to be injected with the needle), and the term “proximal” may be used herein to identify a location farther away from the outlet of the needle. As discussed below, the dispenser 10 may form an aspect of a medication delivery device. While some aspects of the medication delivery device may be described herein and / or shown in the drawings, it should be appreciated that someaspects of the medication delivery device may not be shown in the figures and / or described, or may not be shown in the figures and / or described in detail. For example, a housing of the medication delivery device may house the dispenser 10. The housing of the medication delivery device may include other components and electronics to make the dispenser operable. For example, the housing may also include one or more motors for driving movement in or relative to the dispenser 10, and a computer processor for controlling operation of the one or more motors.

[0087] FIG. 2 shows a perspective view of the cartridge assembly 100 in an assembled state, and FIG. 3 shows a perspective view of the cartridge assembly 100 in a partially disassembled state, according to some embodiments of the present technology. The cartridge assembly 100 may comprise a cartridge 150 configured to hold a fluid (e g., a liquid medication) therein. The fluid may be confined to a fluid chamber 158 delimited by a piston 156 configured to seal a proximal opening of the cartridge 150, and delimited by a septum 152 configured to seal a distal opening of the cartridge 150. A septum retainer 154 may be coupled to a distal end of the cartridge 150 to hold the septum 152 in place at the distal opening of the cartridge 150. In some embodiments, the piston 156 may be configured to provide a movable seal against an internal surface of the cartridge 150, to prevent the fluid in the fluid chamber 158 from leaking out of a proximal end of the fluid chamber 158 even during movement of the piston 156 along the internal surface of the cartridge 150. The septum 152 may be formed of a self-sealing material (e.g., an FDA-rated elastomeric material such as medical -grade silicone, medical -grade ethylene propylene diene monomer (EPDM), and the like) that may be pierced by a piercing object of the needle system 200 during an injection process, to enable the fluid in the fluid chamber 158 to flow out of the fluid chamber 158 during the injection process, and that may reseal to provide a fluid-tight seal after the piercing object is retracted from the septum 152. In some embodiments, the retraction of the piercing object out of the septum 152 and the subsequent resealing of the septum 152 may prevent contamination of the fluid remaining in the fluid chamber 158, such that the remaining fluid may be used in future injection processes. In some embodiments, the fluid inthe fluid chamber 158 may be sufficient for multiple injections (e.g., multiple doses of medication).

[0088] Devices according to the present disclosure may carry and dispense one or more liquid medications, which may also be referred to as medications or drugs and maybe held in the fluid chamber 158. Such medications may include, for example, epinephrine, anaesthetics, analgesics, steroids, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GLP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide or retatrutide, basal insulins, such insulin efsitora alfa, oxyntomodulin analogs, oxyntomodulin derivatives, and other treatments for diabetes and / or obesity, such as with lepodisiran (LPA siRNA), volenrelaxin, amylin agonist long acting, PNPLA3 siRNA, APOC3 siRNA, DACRA qw II, GIPR agonist long acting, glucose sensing insulin receptor agonist, nisotirostide, bimagrunab, NRG4 agonist, SCAP siRNA, mazdutide, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab that can be used for treatment of Crohn’s disease or ulcerative colitis, IL- 17 antibody analogs or derivatives, such as ixekizumab that can be used for treatment of plaque psoriasis, IL- 13 antibody analogs or derivatives, such as lebrikizumab that can be used for treatment of atopic dermatitis, therapeutic agents for pain-related and / or migraine treatments, such as galcanezumab or lasmi ditan, or for treatment of atopic dermatitis, such as with ucenprubart, for treatment of Alzheimer’s and / or dementia, such as with donanemab, remternetug, or GRN gene therapy, for treatment of Parkinson’s disease and / or Gaucher’s disease, such as with GBA1 gene therapy, for treatment of Hidradenitis Suppurativa, such as with eltrekibart, for treatment of rheumatoid arthritis, such as with peresolimab, and any therapeutic agent, such as with CD 19, that is capable of delivery by the devices described herein. Devices according to the present disclosure may be operated in a manner generally as described herein by a user (for example, a healthcare professional, a caregiver, or another person) to deliver one or more medications to a patient (for example, another person or the user).

[0089] The cartridge 150 may be held in a housing 102 of the cartridge assembly 100. In some embodiments of the present technology, the housing 102 may have a cylindrical shape, as depicted in FIG. 3, and a plurality of ribs 114 may extend radially from an internal surface of the housing 102. The ribs 114 may serve as spacers that keep the cartridge 150 at a predetermined position in a cartridge chamber 108 of the housing 102. In some embodiments, the ribs 114 may have rib shoulders 114a configured to serve as an axial insertion limit of the cartridge 150 in the housing 102. In some embodiments, when the cartridge 150 is fully inserted in the cartridge chamber 108, an edge at a proximal end of the cartridge 150 may abut the rib shoulders 114a and the cartridge 150 may be radially centered in the cartridge chamber 108. In some embodiments, when the cartridge 150 is fully inserted in the cartridge chamber 108, the septum 152 may extend out of a distal end of the housing 102, such that the septum 152 may be positioned in a recess of the needle system 200.

[0090] In some embodiments of the present technology, the cartridge assembly 100 may comprise a drive assembly 300 configured to drive movement of the piston 156 to eject the fluid in the fluid chamber 158 out of the distal end of the cartridge 150. The drive assembly 300 may be referred to as a “driven” assembly because the drive assembly 300 may itself be driven to move and, in turn, may convert a received drive force to a force that causes the piston 156 to move along an axis A of the cartridge assembly 100. In some embodiments, the drive assembly 300 may comprise a driven mechanism 302, which may be a drive gear 302 configured to be driven to rotate about the axis A. The driven mechanism 302 may comprise a spindle 302a around which an axially extendible member 306 may be wound. In some embodiments, the axially extendible member 306 may be a ribbon (element 306 may refer to either the axially extendible member or the ribbon interchangeably) having a distal end attached to a foot 304. The foot 304 may be configured to rotate relative to the distal end of the rotating ribbon 306. The drive assembly 300 may be configured such that rotation of the driven mechanism 302 causes the ribbon 306 to extend or expand along the axis A when the driven mechanism 302 is rotated in a first direction. In some embodiments, the driven mechanism 302 may cause the ribbon 306 to retract when the driven mechanism 302 is rotated in a second direction opposite tothe first direction. As discussed below, when the ribbon 306 is driven to extend, an axial distance between the distal and proximal ends of the ribbon 306 expands or increases, causing the foot 304 to be moved axially. When the foot is in contact with the piston 156, expansion of the ribbon 306 causes the piston 156 to move axially toward the distal opening of the cartridge 150. In some embodiments, precise control of an amount of rotation of the driven mechanism 302 may cause a precise amount of expansion of the ribbon 306 and a precise amount of movement of the piston 156, which in turn may cause a precise amount of fluid to be ejected. Additional ribbon-expansion mechanisms are described in WO2017 / 165154A1,WO2019 / 118626A1, and WO2019 / 112886A1, each of which is incorporated herein by reference in its entirety.

[0091] FIGs. 4A and 4B show perspective views of longitudinal cross-sections of the cartridge assembly 100, according to some embodiments of the present technology. FIG. 4C shows a perspective view of a cross-section of the cartridge assembly 100 cut along a plane 4C in the view of the cartridge assembly 100 shown in FIG. 4A, according to some embodiments of the present technology. In FIGs. 4A and 4B, the foot 304 of the drive assembly 300 is spaced apart from the piston 156. As will be appreciated, during an injection process, the foot 304 may be in contact with the piston 156. A distal surface of the foot 304 may comprise a groove 304a configured to engage with protrusions 156a on a proximal surface of the piston 156. For example, the groove 304a may be circular and the protrusions 156a may be bumps configured to fit in the groove 304a when the foot 304 and the piston 156 are abutted to each other. In some embodiments, the foot 304 may be configured to rotate about the axis A while the protrusions 156a remain rotationally fixed when the piston 156 is being pushed by the foot 304.

[0092] According to some embodiments of the present technology, the foot 304 may be connected to the distal end of the ribbon 306 by a bearing 308, which may rotate during expansion and retraction of the ribbon 306 and which may enable the foot 304 to remain rotationally stationary during expansion and retraction of the ribbon 306. In some embodiments, a proximal surface of the foot 304 may have a socket recess configured to receive a ball-shapedprotrusion of the bearing 308, which may rotate in the socket recess during expansion and retraction of the ribbon 306.

[0093] FIG. 4F is a perspective view of the proximal surface of the foot 304, according to some embodiments of the present technology. FIG. 4G is a perspective view of the bearing 308 attached to the ribbon 306, according to some embodiments of the present technology. The proximal surface of the foot 304 may be contactable with the distal surface of the bearing 308 (as shown in FIG. 4A), whereas the distal surface of the foot 304 may be contactable with the piston 156. The foot 304 may have a recess configured to receive a protrusion of the bearing 308, as shown in FIG. 4A. In one example, the proximal surface may comprise a curved concave well 304c on which a curved convex surface 308a of the bearing 308 may push against and rotate during an injection operation. In some embodiments, the bearing 308 may comprise a peripheral edge extending from a reduced cross-sectional area stem, where the edge is used to retain the bearing 308 in the well 304c. In some embodiments, the foot 304 may comprise one or more retaining structures 304b that extend radially inward from adjacent side wall that is configured to retain the edge of the bearing 308 in the well 304c such that the bearing 308 may rotate relative to the well 304c. For example, the structures 304b may comprise overhangs configured to hold portions of the edge of the bearing 308 therein. In some embodiments, one of or both of the foot 304 and the bearing 308 may be formed of a low-friction hard plastic. For example, the bearing 308 and / or the foot 304 may be formed of any one or any combination of: polyimide, nylon, polyoxymethylene (POM), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polycarbonate, and the like. In some embodiments, the well 304c may be filed with a silicone grease.

[0094] FIG. 4D shows a plan view of a slice of the cartridge assembly 100 cut along parallel planes 4D in the view of the cartridge assembly 100 shown in FIG. 4A, according to some embodiments of the present technology.

[0095] According to some embodiments of the present technology, the ribbon 306 may be wound around the spindle 302a such that, when the ribbon 306 is in a fully retracted state, some or all of the ribbon 306 may be coiled, such that loops of the coil may have proximal edges thatare generally aligned with each other and distal edges that are generally aligned with each other. Thus, when the ribbon 306 is fully retracted, the coil may be compact and may fit in a ribbon chamber 110 of the housing 102 located at a proximal end 104 of the housing 102. In some embodiments, when the driven mechanism 302 is rotated to expand the ribbon 306, axially elongated spindle ribs 302b protruding radially from a longitudinal portion of the spindle 302a may bear against rib latches 306c protruding from a surface of the ribbon 306, causing the ribbon 306 to rotate and uncoil. In some embodiments, the spindle ribs 302b and the rib latches 306c may be structured to have complementary angles to latch or hook to each other, as depicted in FIG. 4D. In some embodiments, the ribbon 306 may uncoil to form a helix having an axial length controlled by an amount of rotation of the driven mechanism 302. Thus, through controlled rotation of the driven mechanism, controlled movement of the piston 156 may be achieved and, consequently, controlled ejection of the fluid in the fluid chamber 158 may be achieved. In some embodiments, the cartridge assembly 100 may be structured such that a predetermined number of rotations of the driven mechanism 302 may result in movement of the foot 304 by 0.2 mm or 0.3 mm or 0.4 mm or 0.5 mm. In some embodiments, one complete rotation (e.g., a rotation of 360°) may result in a known amount of movement of the foot 304 and / or a known amount of movement of the piston 156 pushed by the foot 304.

[0096] According to some embodiments of the present technology, the ribbon 306 may be uncoiled from “inside to outside” such that an innermost loop of the coil in contact with the spindle ribs 302b uncoils first and extends or expands to form a growing helix. For example, FIGs. 3, 4A, and 4B depict a retracted portion 306a of the ribbon 306 formed of outer coil loops of the ribbon 306, and depict an extended portion 306b of the ribbon 306 extending from an inner coil loop of the ribbon 306 to form a helix.

[0097] The helix formed from an extended portion 306b of the ribbon 306 may be guided from the ribbon chamber 110 of the housing 102 to the cartridge chamber 108 of the housing by a helix guide 112. An unextended or retracted portion 306a of the ribbon 306 may remain coiled in the ribbon chamber 110. In some embodiments of the present technology, the helix guide 112 may be a tubular section of the housing 102 having a diameter that is smaller than a diameter ofthe cartridge chamber 108. A diameter of the helix may correspond to the diameter of the helix guide 112. In some embodiments, the ribs 114 of the housing 102 may extend radially from the internal surface of the housing 102 and may contact an external surface of the helix guide 112, as depicted in FIG. 4D.

[0098] FIG. 4E shows a plan view of a proximal end 104 of the cartridge assembly 100, according to some embodiments of the present technology. The driven mechanism 302 may fit in the ribbon chamber 110 of the housing 102 and may rest on a lip 110b extending from an inner surface of the ribbon chamber 110 (see FIG. 5). The driven mechanism 302 may be structured to engage with and be rotated by a driver, discussed below. In some embodiments, a surface of the driven mechanism 302 may comprise a recess 302c configured to receive a spline shaft therein. The recess 302c may be formed in a spindle base 302e of the spindle 302a from which the longitudinal portion extends therefrom. The spindle base 302e may include a diskshaped body having a spindle-base diameter. The recess 302c may have recessed teeth 302d configured to mate with corresponding teeth of the spline shaft. As will be appreciated, the driven mechanism 302 may be configured with other structures that enable the driven mechanism 302 to be rotated. For example, instead of the recess 302c, the surface of the driven mechanism 302 may be provided with a shaft (e.g., a spline shaft) configured to engage with and be rotated by a motorized apparatus having a recess (e.g., a spline-shaped recess) that mates with the shaft.

[0099] FIG. 5 schematically shows an plan view of a longitudinal cross-section of a portion of a proximal end of a first variation 5 A and a second variation 5B of the cartridge assembly 100, according to some embodiments of the present technology. The first and second variations 5A, 5B may be comprised a housing 102’ that is a variation of the housing 102. The first variation 5 A may comprise a ribbon container 116 that may be insertable in the housing 102, which may facilitate manufacturing by enabling a ribbon bobbin comprising the ribbon container 116, the ribbon 306, and the driven mechanism 302 to be manufactured separately and to be easily installed as a unit in the housing 102’. In some embodiments, a ribbon chamber 110’ of the ribbon container 116 may have a distal base that is sloped to facilitate helix formation byproviding room for inner loops of the coil to uncoil while outer loops are relatively more confined to stay together in the coil. The second variation 5B may comprise a ribbon container 116’ that is similar to the ribbon container 116 but may have a ribbon chamber 110” that is smaller in volume than the ribbon chamber 110’ of the first variation 5A, with an axially shorter dimension resulting in an axially tighter ribbon chamber 110”. The axially tighter ribbon chamber 110” may be sized closely to associate with an edge-to-edge width of the ribbon in order to facilitate a reduction of binding and slippage when the ribbon 306 is moving to an extended configuration. The second variation 5B may comprise a driven mechanism 302’ that has a recessed outer surface, in which a peripheral edge of the driven mechanism 302’ may be flush with the proximal edge 102a’ of the housing 102’ but a remainder of the driven mechanism 302’ may be sunken relative to the proximate edge 102a’. Such a sunken configuration may advantageously enable a more secure engagement of the driven mechanism 302’ with a driver, thus enabling a higher degree of confidence that a rotation or a partial rotation of the driven mechanism 302’ will result in a predictable axial movement of the plunger 156. In another variation, the ribbon container 116, 116’ may not be a component that is insertable in the housing 102’ but may instead be an integral structure of the housing 102’. For example, the housing 102’ may formed of molded plastic such that a ribbon chamber of the housing 102’ may have an internal structure corresponding to the ribbon container 116, 116’ . As depicted in FIG. 5, a surface of the spindle 302a, 302a’ may have a tapered profile, such that a diameter of the spindle 302a, 302a’ may decrease gradually from a relatively larger diameter at a proximal end of the spindle 302a, 302a’ to a relatively small diameter at a distal end of the spindle 302a, 302a’. In some embodiments, the spindle 302a, 302a’ may have a conical shape. The tapered profile of the spindle 302a, 302a’ may enable a smooth movement of the ribbon 306 relative to the spindle 302a, 302a’ as the helix axially expands in length. For example, the tapered profile may enable an innermost coil of the ribbon 306 to uncoil gradually and become part of the expanding helix. In some embodiments, the spindle ribs 302b, 302b’ may extend radially from the tapered surface of the spindle 302a, 302a’ such that a radial distance d of a radially outer edge of each of the spindle ribs 302b, 302b’ to the axis A may be the same along an axial length of each of thespindle ribs 302b, 302b’, as depicted in FIG. 5. Such a configuration of spindle ribs 302b, 302b’ may cause the helix to have a columnar shape.

[0100] FIGs. 6A and 6B show elevational side views of the ribbon 306 in an unstressed state, according to some embodiments of the present technology. In FIGs. 6A and 6B, a distal end of the ribbon 306 is on the left and a proximal end of the ribbon 306 is on the right. The distal end of the ribbon may be structured as a latch 306f that may engage directly with the foot 304 or that may engage with the bearing 308, discussed herein.

[0101] According to some embodiments of the present technology, the ribbon 306 may be formed of a resilient material such that, when not confined in the ribbon chamber 110 and in an absence of a force exerted on the ribbon 306 (e.g., in the unstressed state), the ribbon 306 may form a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix, as depicted in FIGs. 6A and 6B. The tapering may be formed along the cross-sectional area of the helix increasing along the axis A from the distal end to the proximal end. The tapered helix may or may not have a gap between segments or loops of the helix when seen in a side view (e.g., the views of FIGs. 6A and 6B). FIG. 6C shows an end view of the ribbon 306 in the unstressed state, with an external surface of the latch 306f being visible (e.g., looking from the distal end toward the proximal end of the ribbon 306. FIG. 6D shows an end view of the ribbon 306 in the unstressed state, with an internal surface of the latch 306f being visible (e.g., looking into the tapered helix from the proximal end toward the distal end of the ribbon 306). An advantageous aspect of the ribbon 306 having a tapered structure is that such a structure may facilitate manufacturing of the cartridge assembly 100. With a tapered structure, the ribbon 306 may be easily collapsed into a coil by applying an axial force to squeeze the distal end and the proximal end toward each other (e.g., by a pinching action between two fingers), and may facilitate insertion of the coil onto the spindle 302a and into the ribbon chamber 110. For example, the tapered helix may collapse to form a coil when a first end of the tapered helix is placed against a flat surface (e.g., a table) and an axial force is exerted on a second end towards the flat surface. Materials of the ribbon 306 and molding techniques may be applied to result in a desired tapering profile.

[0102] According to some embodiments of the present technology, the rib latches 306c of the ribbon 306, discussed above, may protrude from one of the two surfaces of the ribbon 306. In some embodiments, the rib latches 306c may protrude from a surface forming an interior surface of the tapered helix, as shown in FIGs. 6A, 6B, and 6C. The rib latches 306c may be configured to engage with and slide along the spindle ribs 302b when the ribbon 306 is axially expanding or extending. In some embodiments, as discussed above, the rib latches 306c of the innermost loop of the coil (e.g., the innermost loop of the retracted portion 306a of the ribbon 306) may be in contact with the spindle ribs 302b and may be rotated by rotation of the spindle ribs 302b to form a growing or elongating helix. The innermost loop of the coil may be a continuously changing portion of the ribbon 306 as the helix elongates. The rib latches 306c that slide along the spindle ribs 302b may slide off the spindle ribs 302 consecutively as the helix elongates. Similarly, the rib latches 306c of the retracted portion 306a of the ribbon 306 may engage with the spindle ribs 302b consecutively as the helix elongates. In some embodiments, computerized control of an amount of rotation of the drive mechanism 302 may cause the ribbon 306 to be expanded to one or more predetermined positions, with each predetermined position corresponding to a known amount (or an known incremental amount) of the fluid being ejected out of the fluid chamber 158 relative to a previous predetermined position.

[0103] According to some embodiments of the present technology, a groove 310 may be provided on a surface of the ribbon 306 opposite to the surface on which the rib latches 306c are provided. In some embodiments, the groove 310 may be provided on an exterior surface of the ribbon 306, as shown in FIGs. 6A and 6B. The groove 310 may be configured to slide along a protruding bump portion 110a proximate a proximal end of the helix guide 112. In some embodiments, movement of the ribbon 306 along the bump portion 110a and along the spindle ribs 302b may cause the elongating helix to be columnar or cylindrical, which structurally may provide the helix with enhanced rigidity against the piston 156 while pushing against the piston 156. In some other embodiments, movement of the ribbon 306 along the bump portion 110a and along the spindle ribs 302b may cause the elongating helix to be tapered or conical. In some embodiments, the bump portion 110a may be a helical ridge I l la, I l la’ on an internal surface ofthe ribbon container 116, 116’. The helical ridge I l la, I l la’ may fit in and slidably engage with the groove 310 during elongation of the helix.

[0104] The edges of the ribbon may include complementary coupling features allowing adjacent edges of the ribbon to mate when the helical configuration is formed and the ribbon is axially extending, and, in some embodiments, to decouple from one another when transitioning to the coil configuration when the ribbon is being retracted. According to some embodiments of the present technology, the ribbon 306 may comprise a plurality of pegs 306d positioned along a first edge of the ribbon 306, and may comprise a plurality of holes 306e positioned along a second edge opposite to the first edge of the ribbon. In some embodiments, the pegs 306d may protrude from the surface forming the interior surface of the ribbon 306, as depicted in FIGs. 6A, 6B, and 6C. That is, the pegs 306d and the rib latches 306c may protrude from the same surface of the ribbon 306, with the rib latches 306c extending longitudinally from an edge region near the pegs 306c to the second edge of the ribbon 306. The pegs 306d and the holes 306e may be configured such that, when the ribbon 306 is expanding or extending, an increasing number of the pegs are received in an increasing number of the holes to form the helix such that each loop of the helix is interlocked with at least one adjacent loop of the helix.

[0105] While FIGs. 6A and 6B shows the ribbon 306 in an extended configuration forming a tapered helix, it should be appreciated that this is for illustrative purposes to show aspects of the ribbon 306, which may allow the ribbon 306 to unwind from the coil in a zipper-like configuration to form the helix, so that the ribbon 306 unwinds in a structured manner on itself, with lower edges of loops of the helix (e.g., formed of a lower edge of the ribbon 306) attaching to upper edges of the loops of the helix (e.g., formed an upper edge of the ribbon 306) as the ribbon 306 expands, as discussed herein. In some embodiments, the ribbon 306 may be manufactured and deployed in the cartridge assembly 100 as shown in FIG. 1, with the ribbon 306 being wound around itself such that some, most, or all of the ribbon 306 is retracted in a coil having a height corresponding to an edge-to-edge distance of the ribbon 306 (e.g., without requiring a force to be exerted on the ribbon 306 to maintain the ribbon 306 in the coil). As a result, in an initial configuration (e.g., prior to use of the dispenser 10 to administer any of thefluid in the fluid chamber 158), some, most, or all of the ribbon 306 may be retracted and wound around itself in the coil. As the ribbon 306 extends and joins upon itself to form a helix, as discussed herein, a structured and tapered shape may result or a columnar shape may result, each of which may provide accurate and effective dosing through accurate expansion of the helix.

[0106] FIGs. 7A and 7B show perspective views of the cartridge assembly 100 and a driver gear 402 configured to rotationally drive the driven mechanism 302 of the drive assembly 300, according to some embodiments of the present technology. FIG. 7C shows a perspective view of the driver gear 402. In some embodiments, the driver gear 402 may be included as part of a cassette and may be incorporated in a housing of the cassette. In some embodiments, the driver gear 402 may comprise a disk-shaped body having a driver-gear diameter and gear teeth circumferentially spaced relative to one another along the circumferential edge surface of the disk shaped body. In some embodiments, the driver gear 402 may comprise a spline shaft 404 extending from an axially facing surface of the driver gear 402. The spline shaft 404 may be configured to fit into the recess 302c in the surface of the driven mechanism 302, and the spline shaft 404 may have teeth configured to engage with the recessed teeth 302d of the recess 302c. The recess 302c and a body of the spindle 302a may have a coaxial relationship along the longitudinal axis A, as shown in FIGs. 7A and 7B. In some embodiments, the driver gear 402 may be a spur-type gear configured to be driven to rotate via a force applied to teeth 402a of the driver gear 402. Rotation of the driver gear 402 may drive rotation of the driven mechanism 302 via the spline shaft 404 of the driver gear 402 and the recess 302c and teeth 302d of the driven mechanism 302. In some embodiments, when the cartridge assembly 100 is inserted into a housing of a cassette, the spline shaft 404 may be located along the longitudinal axis A to facilitate an insertion coupling of the spline shaft 404 with the recess 302c of the cartridge assembly 100, which may be located along the longitudinal axis A. The driver gear 402 and the driven mechanism 302 may be arranged together and may advantageously reduce an amount of thrust experienced by the ribbon 306 and by the cassette. In some embodiments, the driver-gear diameter of the body of the driver gear 402 may be at least greater than a spindle-base diameter of the spindle base 302e of the spindle 302a.

[0107] FIG. 8 shows a perspective view of the dispenser 10, according to some embodiments of the present technology. In FIG. 8, a housing 202 of the needle assembly 200 is depicted as translucent so that internal components may be seen. FIG. 9A shows a perspective view of the needle assembly 200, and FIG. 9C shows a perspective view of the needle assembly 200 in a partially disassembled state. FIG. 9B shows a plan view of a cross-section of the needle assembly 200 cut along a plane 9B in FIG. 9A.

[0108] According to some embodiments of the present technology, the needle assembly 200 may be attached to the distal end of the cartridge assembly 100, such that the septum 152 of the cartridge assembly 100 is received in a recess of the needle assembly 200. In some embodiments, during an injection process, a piercer of the needle assembly 200 may be driven to pierce the septum 1 2 to enable the fluid in the fluid chamber 158 be ejected out of the fluid chamber 158. For example, the septum 152 may be pierced according to techniques described in WO2022 / 132675Aland WO2022 / 132677A1, each of which is incorporated by reference herein in its entirety. Examples of a housing of the medication delivery device that may be coupled to the dispenser 10 may be found in these documents. In some embodiments in which the fluid is a liquid medication, the fluid ejected from the fluid chamber 158 may be injected into a patient through a needle 216 of the needle assembly 200. The needle assembly 200 may carry a single needle or a plurality of needles (e.g., two needles, three needles, four needles, etc.), as discussed herein.

[0109] According to some embodiments of the present technology, the needle assembly 200 may comprise a plurality of needles 216 that may be individually activated for use. The needle assembly 200 may comprise a needle-selection gear 204, which may be driven to move a selected one of the needles 216 to an activated position. The selected needle 216 may be a next one of the plurality of needles 216 or may be a particular one of the plurality of needles 216. The selected needle 216 may be rotated into the activated position by rotation of the needleselection gear 204 through action of a driver assembly 600 (FIG. 19), discussed below. In some embodiments, each needle 216 of the needle assembly 200 may be operatively connected to a needle-movement gear 208 and a gear assembly 208a, which may be configured to move theneedle 216 axially from a retracted position in the housing 202, at which a needle tip is retracted from a base surface 202c at a distal end of the housing 202, to an injection position, at which the needle tip extends beyond the base surface 202c (e.g., into a patient). If a needle 216 is not in the activated position, the needle 216 cannot move from the retracted position to the injection position.

[0110] According to some embodiments of the present technology, when a needle 216 is in the activated position (“activated needle”), a transfer gear 206 of the needle assembly 200 may drive movement of the needle 216 to and from the injection position and the retracted position. The transfer gear 206 also may be referred to herein as an idler 206. In some embodiments, when in the activated position, teeth of the needle-movement gear 208 of the activated needle 216 may be intermeshed with teeth of the transfer gear 206, such that rotation of the transfer gear 206 may drive rotation of the needle-movement gear 208. The transfer gear 206 may be driven to rotate through action of a driver assembly 400 (FIG. 19), discussed below. Rotation of the needle-movement gear 208 by the transfer gear 206 may cause the activated needle 216 to move axially from the retracted position to the injection position.

[0111] The inventors have recognized and appreciated that safety is an important consideration in use of the dispenser 10, especially when the dispenser 10 is to be used by lay persons who are not trained in handling needles and / or injection fluids (e.g., liquid medications). The inventors have therefore provided gear-lock mechanisms for the dispenser 10. The gearlock mechanisms may prevent the needle- sei ection gear 204 from placing any of the needles 216 in the activated position and / or may prevent the transfer gear 206 from moving any of the needle-movement gears 208 unless certain unlocking features are satisfied, as discussed herein.

[0112] One such gear-lock mechanism is a lock spring 210, which may comprise a U-shaped spring face 210a configured to prevent rotation of the needle-selection gear 204 and to prevent rotation of the transfer gear 206 when the lock spring 210 is in a locked position. FIG. 9B shows a surface of the needle assembly 200 on the left of the plane 9B (see FIG. 9A), with the lock spring 210 in the locked position, according to some embodiments of the present technology. When the lock spring 210 is in the locked position, projections 210b of the spring face 210a arelodged in spaces in the needle assembly 200, preventing rotation of the needle-selection gear 204. For example, the projections 210b may straddle one of the gear assemblies 208a, as shown in FIG. 9B, or may be inserted between two of the gear assemblies 208a, such that the projections 210b block rotation of the needle-selection gear 204 and may block movement of a needle 216 into the activated position. Additionally, when the lock spring 210 is in the locked position, a base of the spring face 201a may abut against the transfer gear 206 to prevent rotation of the transfer gear 206. For example, a protrusion on a stem portion of the transfer gear 206 may be seated in a recess in the base of the lock spring 210 such may that the transfer gear 206 may not rotate. In some embodiments, the lock spring 210 and the transfer gear 206 may be mounted on a support frame 212 of the needle assembly 200. The support frame 212 may be attached to a needle subassembly 214 comprising the needles 216, the needle-selection gear 204, and the needle-movement gears 208, and may be positioned such that the transfer gear 206 may rotate the needle-movement gear 208 of a needle 216 in the activated position when the lock spring 210 is in an unlocked position. In some embodiments, the transfer gear 206 may be movably mounted on a frame post 212a of the support frame 212, and the projections 210b of the spring face 210a may straddle the transfer gear 206 and the frame post 212a, as depicted in FIG. 9B. As discussed below, when the lock spring 210 is moved from the locked position to the unlocked position, the base of the spring face 210a may be shifted away from the transfer gear 206, and the projections 210b of the spring face may be shifted away from the gear assemblies 208a, thus enabling the needle-selection gear 204 to rotate a selected one of the needles 216 into the activated position adjacent the transfer gear 206 and also enabling the transfer gear 206 to rotate and drive the needle-movement gear 208 of the activated needle 216.

[0113] FIG. 10 shows a perspective view of a cassette 20 comprising the dispenser 10 partially inserted in a cassette housing 22, according to some embodiments of the present technology. In some embodiments, when the needle assembly 200 and the cartridge assembly 100 are assembled together to form the dispenser 10 but the dispenser 10 is not installed in the cassette housing 22, the lock spring 210 is in the locked position. This may serve as a safety mechanism that prevents accidental movement of the needles 216 into the injection position. Insome embodiments, the cassette housing 22 may comprise a compartment 26 configured to receive the needle assembly 200. When the dispenser 10 is fully inserted in a cavity of the cassette housing 22, a portion of the compartment 26 may cause the lock spring 210 to move into the unlocked position.

[0114] FIG. 11 A shows a perspective view of a partial longitudinal cross-section of the needle assembly 200 partially inserted in the compartment 26 of the cassette housing 22, according to some embodiments of the present technology. Because the needle assembly 200 is not fully inserted in the compartment 26, the lock spring 210 of the needle assembly 200 may be in the locked position. In some embodiments, when a base 24 of the cassette housing 22 is not aligned with a base 202c of the housing 202 of the needle assembly 200, the needle assembly 200 may not be fully inserted in the compartment 26 such that an internal recess 28b of the compartment 26 is not engaged with an edge portion of the housing 202, as depicted in FIG. HA. An arrow in FIG. 11A shows a direction of movement of the needle assembly 200 relative to the cassette housing 22 during installation of the dispenser 10 into the cassette housing 11. The compartment 26 may comprise a base 26a supporting a tang base 28a and a tang 28 protruding axially from the tang base 28a. The tang 28 may be configured to engage with the lock spring 210 to move the lock spring 210 from the locked position to the unlocked position when then needle assembly 200 is fully inserted in the compartment 26 of the cassette housing 22. FIG. 1 IB shows the needle assembly 200 fully inserted in the compartment 26 of the cassette housing 22, such that the base 24 of the cassette housing 22 is coplanar with the base 202c of the housing 202 of the needle assembly 200. When fully inserted, the tang 28 extending from the base 26a of the compartment 26 may push against a portion of the lock spring 210 to compress the lock spring 210 and move the lock spring 210 such that the base of the spring face 210a may be shifted away from the transfer gear 206 and the projections 210b of the spring face 210a may be shifted away from the gear assemblies 208a, thus placing the lock spring 210 in the unlocked state. Such shifting enables the needle-selector gear 204 to rotate, thus enabling a selected one of the needles 216 to be moved to the activated position and also enabling the transfer gear 206 to rotate to drive the needle-movement gear 208 of the activated needle 216.

[0115] FIGs. 12A shows a perspective view of a distal section of a dispenser 40, according to some embodiments of the present technology. The dispenser 40 may be similar in many respects to the dispenser 10 described above. Portions of the dispenser 40 that are the same as the dispenser 10 may be represented by the same reference numerals. Portions of the dispenser 40 that are modifications of the dispenser 10 may be represented by modified versions of the same references numerals (e.g., with the addition of ’ or ” after the reference numeral). In some embodiments, the gear-lock mechanism of the dispenser 40 may be different from the gear-lock mechanism of the dispenser 10. FIG. 12B shows the same view as FIG. 12A but with the housing 202’ of the needle assembly 200’ of the dispenser 40 appearing translucent. FIG. 12C shows a perspective view of the distal section of the dispenser 40 in a partially disassembled state, according to some embodiments of the present technology.

[0116] According to some embodiments of the present technology, the gear-lock mechanism of the dispenser 40 may comprise a lock spring 211, which may comprise a lock plate 211a and a coil spring 211b configured to prevent rotation of the needle-selection gear 204 and to prevent rotation of the transfer gear 206’ when the lock spring 211 is in a locked position. FIG. 13 A shows a view of a longitudinal cross-section of the needle assembly 200’ in a locked state, and FIG. 13B shows the same view of the needle assembly 200’ in an unlocked state, according to some embodiments of the present technology. In some embodiments, the lock spring 211 and the transfer gear 206’ may be movably mounted on the needle subassembly 214 via the support frame 212’. The coil spring 211b, the lock plate 211a, and the transfer gear 206’ may be movably mounted on the frame post 212a’ of the support frame 212’ such that the coil spring 211b biases the lock plate 211 and the transfer gear 206’ in the unlocked position. In the unlocked position, an end of the frame post 212a’ may be partially disposed in a cavity 206a of the transfer gear 206’. As depicted in FIG. 13A, the coil spring 211b when at rest may bias the lock plate 211a against the transfer gear 206a’ such that the transfer gear 206’ is pushed against ribs or lips 203 protruding from the housing 202’, preventing the transfer gear 206’ from rotating. In this position, the transfer gear 206’ may not be fully meshed with the needlemovement gear 208 of the activated needle 216, as depicted in FIG. 13 A. Additionally, when thecoil spring 211b is at rest, the lock plate 211a may bear against portions of the needle subassembly 214, preventing rotation of the needle-selection gear 204. FIG. 13C shows a plan view of a lateral cross-section of the needle assembly 200’ cut through the lock plate 21 la when the lock spring 211 is in the locked state, showing blocking potions 211c of the lock spring 211 extending into a portion of the needle subassembly 214 and bearing against surfaces of the needle subassembly 214, thus preventing rotation of the needle-selection gear 204. FIG. 13D shows a plan view of a lateral cross-section of the needle assembly 200’ cut through the transfer gear 206’ when the lock spring 211 is in the locked stated, showing the lip 203 of the housing 202’ blocking rotational movement of the transfer gear 206’.

[0117] According to some embodiments of the present technology, when an axial force is applied to the lock spring 211, the lock spring may be moved from the locked position to the unlocked position. A direction of the axial force is represented by an arrow F in FIG. 13B. The axial force may compress the coil spring 211b and may enable axial movement of the lock plate 211a away from blocking rotation of the needle-selection gear 204 and may enable axial movement of the transfer gear 206’ away from the lip 203, thus enabling the needle-selection gear 204 to rotate and also enabling the transfer gear 206’ to rotate. In some embodiments, the axial force may be applied by a driver gear 602, which may be mountable on the cassette housing 22 before or after the dispenser 40 is fully installed in the cassette housing 22. The driver gear 602 may extend through an opening 27b in the cassette housing (see FIGs. 10, 18A and 18C) and may exert the axial force on the transfer gear 206’ to push the transfer gear 206’ away from the lip 203, in the direction of the arrow F. The transfer gear 206’ may, in turn, push the lock plate 21 la in the direction of the arrow F, causing the lock plate 21 la to move away from blocking movement of the needle- sei ection gear 204. In some embodiments, the driver gear 602 may engage with a gear handle 207 (e.g., a slot, a protruding bar, etc.) of the transfer gear 206’ to push the transfer gear 206’ and / or to rotate the transfer gear 206’ . The driver gear 602 may include a portion with a shaft configuration, although other gear configurations are contemplated. In some embodiments, the driver gear 602 may be part of a motor assembly, as discussed below.The cassette 20, 20’ and the motor assembly may be part of a medication delivery device and may be housed at least partially in a housing of the medication delivery device.

[0118] As will be appreciated, application of a force on the transfer gear 206’ in the direction of the arrow F may push the needle assembly 200’ (and the dispenser 40) out of the cassette housing 22. In a related manner, a natural state of the lock spring 210 may prevent the dispenser10 shown in FIGs. 10, 11 A, and 1 IB from staying in the fully inserted position (FIG. 1 IB) and may cause the dispenser 10 to be in a partially inserted position in the cassette housing 22 (FIG.11 A) unless a retaining force is applied to retain the dispenser 10 at the fully inserted position in the cassette housing 22.

[0119] To keep the dispenser 10, 40 in place in the cassette housing 22, a latch mechanism may be used. FIGs. 14A through 14D and 15A through 15C show views of a first type of latch mechanism that may be used, and FIGs. 16A through 16D and 17A through 17C show views of a second type of latch mechanism that may be used, according to some embodiments of the present technology.

[0120] The first type of latch mechanism may comprise a latch 32 configured to engage with a latch receiver 220, according to some embodiments of the present technology. The latch 32 may be movably attached to the compartment 26’ of the cassette housing 22 via a connector 30a. The latch receiver 220 may comprise a protruding ledge on an external surface of the housing 202, 202’ of the needle assembly 200, 200’. The latch 32 may comprise an engagement surface 32a configured to abut the ledge of the latch receiver 220 to retain the needle assembly 200, 200’ in the compartment 26’ when in a latched position, as schematically depicted in FIG. 15 A. The latch 32 also may comprise an actuator 30, which may be manipulated by a user to release the latch 32 from engagement with the latch receiver 220. In some embodiments, the actuator 30 and the latch 32 may be formed as a single structure, with the engagement surface 32a of the latch 32 positioned on an internal surface of the structure and with the actuator 30 positioned on an external surface of the structure. In some embodiments, the latch 32 may be disengaged by the user by sliding the actuator 30 in a lateral release direction (or in a direction having a lateral component) parallel to a contact surface 34 of the cassette housing 22. For example, FIGs. 14Cand 15B show arrows indicating directions of movement of the actuator 30 to release or disengage the latch 32. In some embodiments, a surface of the actuator 30, the contact surface 34 of the cassette housing 22, and a contact surface 218 of the needle assembly 200, 200’ may be generally coplanar, such that when the contact surface 218 of the needle assembly 200, 200’ is placed against an injection surface (e.g., a skin surface of a patient to be injected with the fluid in the fluid chamber 158) the actuator 30 may not be manipulated in the lateral release direction. Such a coplanar structure may advantageously prevent accidental release or disengagement of the latch 32 by the user during an injection process. In some embodiments, the latch 32 and the latch receiver 220 may comprise complementary angled surfaces configured to slide against each other during insertion of installation of the needle assembly 200, 200’ into the compartment 26’ of the cassette housing 22. When the needle assembly 200, 200’ is fully inserted in the compartment 26’, the latch 32 may snap into the latched position when the latch receiver 220 falls into a recess of the latch 32 and the engagement surface 32a of the latch 32 abuts the latch receiver 220, as depicted in FIG. 15 A. In some embodiments, the connector 30a may be a spring that biases the latch 32 such that, once the needle assembly 200, 200’ and the compartment 26’ of the cassette housing 22 are in the latched position, the latch 32 remains latched to the latch receiver 220 until the actuator 30 is manipulated in the lateral release direction, as discussed above. In some embodiments, upon manipulation of the actuator 30 to release or disengage from the latch receiver 220 of the needle assembly 200, 200’, a spring force of the lock spring 210, 211 of the needle assembly 200, 200’ may bias the dispenser 10, 40 to eject the dispenser 10, 40 from the cassette housing 22, as depicted in FIG. 15C.

[0121] The second type of latch mechanism may comprise a latch 32’ configured to engage with the latch receiver 220’, according to some embodiments of the present technology. The latch 32’ may be pivotably attached to the compartment 26” of the cassette housing 22 via a hinge-type connector (not shown). The latch 32’ may comprise an engagement surface 32a’ configured to abut the ledge of the latch receiver 220’ to retain the needle assembly 200, 200’ in the compartment 26” when in the latched position, as schematically depicted in FIG. 17A. The latch 32’ also may comprise an actuator 30’, which may be manipulated by a user to release thelatch 32’ from engagement with the latch receiver 220’. In some embodiments, the actuator 30’ may be configured to pivot the latch 32’ from the latched position (FIG. 17A) to a release position (FIG. 17B). In some embodiments, the latch 32’ may be placed in the release position by the user by sliding the actuator 30’ in a lateral direction (or in a direction having a lateral component) parallel to the contact surface 34 of the cassette housing 22. For example, FIGs. 16C and 17B show arrows indicating a direction of movement of the actuator 30’ to release or disengage the latch 32’. In some embodiments, the surface of the actuator 30’, the contact surface 34 of the cassette housing 22, and a contact surface 218 of the needle assembly 200, 200’ may be generally coplanar, such that when the contact surface 218 of the needle assembly 200, 200’ is placed against an injection surface the actuator 30’ may not be manipulated to cause the latch 32’ to pivot to the release position, to prevent accidental release or disengagement of the latch 32’ during an injection process. In some embodiments, the actuator 30’ may comprise a spring that biases the actuator 30’ such that when the needle assembly 200, 200’ and the compartment 26” of the cassette housing 22 are in the latched position the latch 32’ remains latched to the latch receiver 220’ until the actuator 30’ is manipulated to pivot the engagement surface 32a’ of the latch 32’ away from the latch receiver 220’, as discussed above. In some embodiments, upon manipulation of the actuator 30’ to release or disengage from the latch receiver 220’ of the needle assembly 200, 200’, a spring force of the lock spring 210, 211 may bias the dispenser 10, 40 to eject the dispenser 10, 40 from the cassette housing 22, as depicted in FIG. 17C.

[0122] FIG. 18A shows a view of the cassette housing 22 during insertion of the dispenser 10 into the cassette housing 22, and FIG. 18B shows a view after the dispenser 10, 40 is fully inserted in the cassette housing 22, according to some embodiments of the present technology. In FIG. 18A and 18B, a driver gear 502 for rotating the needle-selection gear 204 of the needle assembly 200 of the dispenser 10 is positioned at an opening 27a in the compartment 26, 26’, 26” through which the driver gear 502 may contact and rotate the needle-selection gear 204. In some embodiments, the driver gear 502 may include a portion with a worm-gear configuration, although other gear configurations are contemplated. In some embodiments, the driver gear 502may be part of a driver gear assembly 502A (FIG. 10) comprising at least one other gear, and the driver gear assembly 502A may be incorporated in a housing of a medication delivery device, as discussed herein. FIG. 18C shows an enlarged of the compartment 26, 26’, 26” of the cassette housing 22, depicting teeth of the needle-selection gear 204 through the opening 27a. Although not fully visible in FIGs. 18A through 18C, an opening 27b is provided in the compartment 26, 26’, 26” to enable the driver gear 602, discussed above, to contact and rotate the transfer gear 206, 206’ of the dispenser 10, 40. As discussed above, in some embodiments, when the dispenser 40 is fully inserted in the cassette housing 22 and the driver gear 602 is mounted to the cassette housing 22, the driver gear 602 may exert a force on the transfer gear 206’ that may move the lock spring 211 to the unlocked position.

[0123] FIG. 19 shows a block diagram of a motor assembly 50 comprising a plurality of driver assemblies 400, 500, 600. The motor assembly 50 may be coupled to a controller 700 configured to drive each of the driver assemblies 400, 500, 600. In some embodiments of the present technology, the controller 700 may comprise at least one computer processor (e.g., a CPU) programed to control the driver assemblies 400, 500, 600 individually or in a coordinated manner with each other. In some embodiments, the driver assembly 400 may comprise the driver gear 402, discussed above, for driving rotation of the driven mechanism 302 of the drive assembly 300. The driver assembly 400 may comprise a motor 403 configured to cause rotation of the driver gear 402. Similarly, in some embodiments, the driver assembly 500 may comprise the driver gear 502, discussed above, for driving rotation of the needle-selection gear 204. The driver assembly 500 may comprise a motor 503 configured to cause rotation of the driver gear 502. In some embodiments, the driver assembly 600 may comprise the driver gear 602, discussed above, for driving rotation of the transfer gear 206, 206’. The driver assembly 600 may comprise a motor 603 configured to cause rotation of the driver gear 602. In some embodiments, the controller 700 may be provided with an actuator (not shown) that enables a user to initiate an injection process. For example, after the user has placed the cassette in an injection position (e.g., against the user’s own skin surface or against a skin surface of a patient), the user may manipulate the actuator to cause an automated and coordinated movement of anyone of or any combination of: (1) a needle 216 of the needle assembly 200, 200’ to be positioned in the activated position through rotation of the needle-selection gear 204 via the driver assembly 600; (2) movement of the drive assembly 300 to cause movement of the piston 156 towards the septum 152, to eject the fluid in the fluid chamber 158 by a predetermined amount corresponding to, e.g., an amount of rotation of the driven mechanism 302; and (3) movement of the transfer gear 206, 206’ to cause the activated needle 216 to move from a retracted position to an injection position and from the injection position to the retracted position. As noted above, movement of the transfer gear 206, 206’ also may cause the septum 152 to be pierced to permit the fluid to be ejected into the activated needle 216.

[0124] As will be appreciated, the cassette housing 22 may have a form different than the form shown in FIG. 10. FIG. 20A shows a view of the cassette 20’ in which the cassette housing 22’ may be shaped generally rectangularly and sized to be easily grasped by a user. In some embodiments of the present technology, the cassette housing 22’ may have rounded edges and / or slightly curved surfaces, as shown. In some embodiments, the cassette housing 22’ may have an internal cavity shaped to receive the dispenser 10. For example, the internal cavity the cassette housing 22’ may have a generally cylindrical portion to receive the cartridge assembly 100 and a compartment 25 shaped to receive the needle assembly 200. FIG. 20B shows a view in which the dispenser 10 is being inserted in the cassette housing 22’ to form the cassette 20’. In some embodiments, the cassette housing 22’ may be configured with a recess to accommodate the driver gear 402. Optionally, a window 22a may be provided in the cassette housing 22’ to enable a position of the piston 156 and / or a level of the fluid to be visible. Although not shown in FIGs. 20A and 20B, the cassette housing 22’ may include openings for the driver gears 502, 602 to contact the needle assembly 200.

[0125] FIG. 21 shows a block diagram of a medication delivery device 1, according to some embodiments of the present technology. In some embodiments, the device 1 may comprise the cassette 20, 20’, the motor assembly 50, and the controller 700, some or all of which may be housed within or partially within a housing of the device 1. In some other embodiments, the controller 700 may be external to the housing of the device 1 and may be configured to controlthe motor assembly 50 remotely through control signals transmitted via a dedicated cable and / or through control signals transmitted wirelessly using known technology for wireless communications.

[0126] FIGs. 22A and 22B are perspective views of a proximal end and a distal end, respectively, of the needle system 2000 mounted to the cartridge assembly 100, according to some embodiments of the present technology. In FIG. 22B, only the cartridge housing 102 of the cartridge assembly 100 is shown for the sake of simplicity.

[0127] According to some embodiments of the present technology, the needle system 2000 may be configured to house at least one needle assembly comprising a movable needle mechanism. During dose delivery, the needle mechanism may transition from: (1) a standby configuration, which may be an unextended or compact configuration before injection, to (2) an injection configuration, which may be an extended configuration where medication may be delivered to a patient, to (3) a retracted configuration, which may be an unextended or compact configuration after injection. The standby and retracted configurations may be a same configuration or may be different configurations. In some embodiments, the extended configuration may be a configuration in which the needle mechanism may pierce the septum 152 of the cartridge 150 to couple the needle mechanism to the cartridge 150 such that fluid may flow from the cartridge 150 into the needle mechanism. In some embodiments, the extended configuration may be a configuration in which the needle mechanism may also pierce the skin of the patient to deliver the medication sub-dermally.

[0128] According to some embodiments of the present technology, the needle system 2000 may comprise a plurality of needle assemblies 800 and a housing 250 in which the needle assemblies 800 may be disposed. In some embodiments, the needle assemblies 800 may be arranged around a common rotational axis R, which may be different from the axis A of the cartridge assembly 100, as shown in FIG. 22B. In some embodiments, the axis R may not be parallel to the axis A. Details of the needle assembly and the needle mechanism are described below.

[0129] FIG. 22C shows a perspective view of the proximal end of the needle system 2000 with the housing 250 removed, according to some embodiments of the present technology. FIG. 22D shows a perspective view of the distal end of the needle system of 2000 with the housing 250 removed and with an identification ring 233 removed. In some embodiments, the needle system 2000 may comprise an indexing gear 232 configured for rotational movement in the housing 250 of the needle system 2000. The needle assemblies 800 of the needle system 2000 may be attached and rotationally fixed relative to the indexing gear 232 such that rotation of the indexing gear 232 may cause rotation of the needle assemblies 800 in the housing 250. The indexing gear 232 may be carousel carrying the needle assemblies 800. In some embodiments, the identification ring 233 may aid in maintaining the needle assemblies 800 within the indexing gear 232. As shown in FIG. 22C, the identification ring 233 may comprise of two segments, which may allow for ease of placing the identification ring 233 over the needle assembly 800 and the indexing gear 232. In other embodiments, the identification ring 233 may be a single segment or may comprise three or more segments. In some embodiments, needle system 2000 without the housing 250 may have a frustoconical shape, with the distal end of the needle system 2000 having a greater area than an area of the proximal end, as shown in FIG. 22C. In some embodiments, gear teeth 232a of the indexing gear 232 may be disposed circumferentially spaced around a peripheral surface of the indexing gear 232. For example, the teeth 232a may be located at an edge of a proximal end of indexing gear 232, as shown in FIGs. 22C and 22D.

[0130] FIG. 22E shows the needle system 2000 and the cartridge assembly 100, with the housing 250, the indexing gear 232, and the identification ring 233 of the needle system 2000 removed so that relative positions of the needle assemblies 800 and the cartridge assembly 100 may be seen. The needle assemblies 800 may each include a needle mechanism, which in some embodiments may be a needle mechanism 810, 1700 discussed below. In some embodiments, the housing 250 may comprise a first section 250b in which some of the needle assemblies 800 may be disposed and a second section 250c in which a driver 245 (discussed below) may be disposed. According to some embodiments of the present technology, the needle system 2000 may comprise four needle assemblies 800 circumferentially arranged around the axis R. Forexample, the four needle assemblies 800 may be arranged such that their distal ends resemble quadrants of a pie, with each of the quadrants having surfaces that may be aligned to form a distal surface 240 of the needle system 2000. In some embodiments, the needle assemblies 800 may be configured to rotate about the axis R such that a selected needle assembly 800 may be rotated into alignment with the cartridge assembly 100. As shown in FIG. 22E, an interior seal 808 of a lower one of the needles assemblies 800 is in alignment with the cartridge assembly 100, while the other non-selected ones are not in alignment. When the selected needle assembly 800 is placed in an aligned position, the driver 245 of the needle system 2000 may engage with the selected needle assembly 800, as shown in FIG. 22E and discussed in more detail elsewhere herein. The driver 245 may be configured to move an injection needle of the selected needle assembly 800 to an injection position such that fluid may flow from the cartridge assembly 100 out of the injection needle. Non-selected ones of the needle assemblies 800 may not be aligned with the cartridge assembly 100, as shown in FIG. 22E. In some embodiments, the needle assemblies 800 may each have a tapered shape such that, when the needle assemblies 800 are arranged together, a radial cross section at or near a distal end of the arrangement (“distal section”) may have an area that is greater than an area of a radial cross section at or near a proximal end of the arrangement (“proximal section”). In some embodiments, each of the needle assemblies 800 may be disposed at least partially in a frustoconical body of the indexing gear 232, as shown in FIG. 22C and 22D, such that the indexing gear 232 and the needle assemblies 800 may be rotated in unison. The tapered shape of the needle assemblies 800 and the frustoconical shape of the needle system 2000 without the housing 250 may aid in reducing an overall size of the needle system 2000. In some embodiments, the needle assemblies 800 may have tapered shapes but the distal ends of the needle assemblies 800 need not be pie-shaped. The tapered shape may correspond to an angle between the axis A and the axis R.

[0131] FIG. 22F shows a perspective view of the needle system 2000 with the first section 250b of the housing 250 appearing translucent so that portions internal to the housing 250 may be seen. According to some embodiments of the present technology, the housing 250 may include a viewer 230 for identifying which of the needle assemblies 800 is in an activatedposition and ready for use in a dose delivery, discussed below. In some embodiments, the identification ring 233 may comprise identifying markings respectively corresponding to the needle assemblies 800, and the viewer 230 may be a window in the housing 250 through which may be seen an identifying marking (e.g., a number, a letter, one or more words, graphics, colors, etc.) for visually indicating which of the needle assemblies 800 is in the activated position. The viewer 230 may allow a user to confirm that a selected needle assembly is the needle assembly 800 in the activated position. The markings may include tactile indicators such as, for example, protrusions and / or recesses of various shapes and sizes. An audible indicator may also be associated with the needle system having a sensor capable of detecting the position of the needle assembly and communicated to the patient the current position of the needle assembly and / or whether the position of the needle has been used or whether a new needle assembly is needed.

[0132] FIG. 22G shows a perspective view of the distal end of the needle system 2000. According to some embodiments of the present technology, the needle system 2000 may be provided with a protective cover 240a covering the distal surface 240. In some embodiments, the protective cover 240a may include an opening or window 242 exposing a distal surface of a selected one of the needle assemblies 800 in the activated position. The material of the cover 240a may also have mechanical properties to inhibit needles from the non-selected ones from piercing the cover inadvertently. During a dose delivery, an injection needle of a selected needle assembly 800 in the activated position may extend through the window 242 to pierce a target surface. In some embodiments, the window 242 may indicate an approximate piercing location of the injection needle. In some embodiments, an identification marking on an exterior surface of the selected needle assembly 800 in the activated position may be seen through the window 242. Thus, the window 242 may allow a user to confirm which needle assembly 800 is being used for an injection and may allow the user to properly position the needle system 2000 on the target surface for the dose delivery. For example, the user may align the window 242 with an area of the target surface to be pierced with the injection needle.

[0133] As noted above, the needle assemblies 800 may be selectively activated for use via the indexing gear 232. According to some embodiments of the present technology, the needleassemblies 800 may be movable within the housing 250 such that a selected needle assembly 800 may be rotated into the activated position via action of the indexing gear. In some embodiments, the activated position may be a position where the selected needle assembly 800 is aligned to pierce the septum 152 of the cartridge 150. The indexing gear 232 may be a needle-selection gear that is driven to move the needle assemblies 800 in an out of the activated position, such that a newly selected needle assembly 800 may be moved to the activated position and a previously selected needle assembly 800 may be moved out of the activated position. For example, the indexing gear 232 may be similar to the needle-selection gear 204 discussed above. The newly selected needle assembly 800 may be, for example, a next one of the needle assemblies 800 adjacent the previously selected needle assembly 800 or may be, for example, a particular one of the needle assemblies 800 not adjacent the previously selected needle assembly 800. In some embodiments, the indexing gear 232 may be coupled to a rotation mechanism configured to rotate the needle assemblies 800 about the axis R. The indexing gear 232 may be driven to rotate and may in turn cause the rotation mechanism to rotate the newly selected needle assembly 800 to the activated position. In some embodiments, the indexing gear 232 may be rotated directly by a shaft of a motor, or may be rotated indirectly by the motor via at least one transfer gear, or may be rotated manually (e.g., by finger scrolling the gear). In some embodiments, the indexing gear 232 may be rotated by a transfer gear disposed at least partially in the housing 250.

[0134] According to some embodiments of the present technology, the housing 250 may include an opening 234 through which a portion of the indexing gear 232 may be accessed to be driven by a component external to the housing 250, as shown inn FIGs. 22F and 23 A. The opening 234 may permit a portion of the teeth 232a of the indexing gear exposed at the opening 234 to interact with, e.g., an indexing driver (not shown). For example, the indexing driver may be similar to the driver gear 502 discussed above.

[0135] According to some embodiments of the present technology, the needle system 2000 may comprise a structure configured to facilitate proper positioning of the selected needle assembly 800 in the activated position. Such structure may maintain the carousel alignment ororientation after assembly and during shipping and handling, all the way until the device indexes the carousel. Also such structure may maintain the carousel position if the disposable is removed and replaced.

[0136] For example, the housing 250 may comprise at least one structure configured to engage with at least one corresponding structure of the indexing gear 232 to indicate that a needle assembly 800 is seated in the activated position. In some embodiments, the housing 250 may comprise a stabilizer 252 configured to engage, one by one, with a plurality of trenches 232b corresponding to the needle assemblies 800, as shown in FIGs. 23 A through 23C. The trenches 232b may have a one-to-one correspondence with the needle assemblies 800. The stabilizer 252 may comprise a protruding peg 252a configured to drag along a surface of the body of the indexing gear 232 during rotation of the indexing gear 232 in a needle selection operation, and to drop into one of the trenches 232b when one of the needle assemblies 800 is aligned with the activated position. The peg 252a is shown extending radially inward, and the trench 232b is shown facing radially outward. In some embodiments, as the indexing gear 232 is rotated, the peg 252a may make an audible sound (e.g., a click), for each alignment that occurs. For example, if Needle Assembly 1 is in the activated position for a previous dose delivery and Needle Assembly 3 is selected for use in a next dose delivery, the indexing gear 232 may be rotated to a first alignment for Needle Assembly 2, at which point there may be a click and / or a physical indication of alignment, and then may be rotated to a second alignment for Needle Assembly 3, at which point there may be another click and / or another physical indication of alignment. In some embodiments, the trenches 232b may comprise a curvature or recess sized to accommodate or seat the peg 252a therein. In some embodiments, during rotation of the indexing gear 232, the stabilizer 252 and the peg 252b may exert a first force radially against the indexing gear 232 such that the indexing gear 232 may experience a first rotational resistance when the peg 252b is not seated in one of the trenches 232b. When one of the needle assemblies 800 is in alignment with the activated position, the stabilizer 252 and the peg 252b may exert a second force, lower than the first force, against the indexing gear 252 such that the indexing gear 232 may experience a second rotational resistance, lower than the first rotational resistance. Thedifference in the first and second rotational resistances and / or the audible clicks may aid in facilitating proper positioning of the selected needle assembly 800 in the activated position and may prevent rotational movement of the selected needle assembly 800 out of position during a dose delivery. In some embodiments, the housing 250 may comprise a plurality of stabilizers 252 (e.g., one stabilizer 252 for each of the trenches 232b).

[0137] FIG. 24 A is a view of a longitudinal cross section of the needle system 2000 showing details of some of the needle assemblies 800 relative to the cartridge assembly 100, according to some embodiments of the present technology, and FIG. 24B shows an enlarged cross section of a portion of the needle system 2000. For simplicity, only the cartridge housing 102 of the cartridge assembly 100 is shown in FIG. 24A.

[0138] According to some embodiments of the present technology, the needle system 2000 may include four needle assemblies 800, of which a first needle assembly 800a and a second needle assembly 800b are shown in FIG. 24A. The first needle assembly 800a is in the activated position in FIG. 24A, in which fluid may be transferred out of the cartridge 150 of the cartridge assembly 100 through the first needle assembly 800a and may exit at a distal end of the first needle assembly 800a when needles of the first needle assembly 800a are extended, as discussed below. In some embodiments, the needle system 2000 may permit only one of the needle assemblies 800 to be in the activated position at any given time. For example, when the first needle assembly 800a is in the activated position, the second needle assembly 800b and other needle assemblies of the needle system 2000 may be prevented from transferring fluid from the cartridge 150.

[0139] According to some embodiments of the present technology, in the activated position, a septum-piercing needle (discussed below) of the first needle assembly 800a may be aligned with the septum 152 of the cartridge assembly 100 such that the septum-piercing needle may be moved along an axis El to pierce the septum 152. In FIG. 24A, the septum 152 is not shown; however, a region 152a where the septum would be located is indicated in FIG. 24A. In some embodiments, the septum-piercing needle of the first needle assembly 800a may be coaxial with the axis A of the cartridge assembly 100 when in the activated position. That is, in someembodiments, the axis El may be coaxial with the axis A. As noted above, when the first needle assembly 800a is aligned with the septum 152, the second needle assembly 800b and the other needle assemblies 800 may not be aligned with the septum 152. For example, as depicted in FIG. 24A, when the first needle assembly 800a is in the activated position, a septum-piercing needle of the second needle assembly 800b may be aligned along a direction Fl such that the septum 152 may not be pierced; similarly, septum -piercing needles of the other needle assemblies 800 not in the activated position also may be aligned along directions that do not permit piercing of the septum 152. In some embodiments, the direction Fl and the axis El may be angled with respect to each another in a range of about 0° to about 15° (e.g., 4°, or 8°, or 10°, or 12°), although larger may be possible. In some embodiments, the direction Fl may be disposed at an angle of about 8° relative to the axis El . It should be appreciated that each of the non-selected ones of the needle assemblies 800 may be oriented at different angles relative to the axis El. In some embodiments, arranging the needle assemblies 800 such that they are inclined relative to one another may decrease an overall size of the needle system 2000 compared to a parallel arrangement of the needle assemblies 800. In other embodiments, the direction Fl may be disposed at an angle of about 0° (or substantially parallel) relative to the axis El .

[0140] According to some embodiments of the present technology, when the first needle assembly 800a is in the activated position, a cannula needle (discussed below) may be moved to pierce a target surface (e.g., a user’s skin). At the same time, cannula needles of the second needle assembly 800b and the other needle assemblies 800 of the needle system 2000 may not be moved to pierce the target surface or any surface.

[0141] According to some embodiments of the present technology, after a dose delivery using the first needle assembly 800a, another one of the needle assemblies 800 of the needle system 2000 may be activated for use. For example, if the second needle assembly 800b is selected to be used next, the second needle assembly 800b may be moved into the activated position via the indexing gear 232 such that the septum-piercing needle of the second needle assembly 800b is aligned with the septum 152 and the axis El. In some embodiments, when the second needle assembly 800b is in the activated position, the septum-piercing needle of thesecond needle assembly 800b may be coaxial with the cartridge assembly 100, as discussed above. When the second needle assembly 800b is in the activated position, the septum-piercing needle of first needle assembly 800a may no longer be in alignment with cartridge assembly 100 and may no longer be aligned along El. Furthermore, when the second needle assembly 800b is in the activated position, the first needle assembly 800a and the other needle assemblies of the needle system 2000 may be prevented from transferring fluid from the cartridge assembly 100.

[0142] As noted above, the needle assemblies 800 that are not in the activated position may not transfer fluid from the cartridge assembly 100. According to some embodiments of the present technology, the cannula needles and the septum-piercing needles of the needle assemblies 800 that are not in the activated position may be prevented from moving, such that the septum 152 may not be pierced and such that the skin of the user may not be pierced by these needles.

[0143] According to some embodiments of the present technology, the needle assemblies 800 may each comprise a driven member 820 configured to cause movement of the cannula and septum -piercing needles, as shown in FIG. 25. The driven members 820 may each be configured to rotate to cause movement of their respective cannula and septum-piercing needles. In some embodiments, the driver 245 of the needle system 2000 may be configured to drive movement of the selected needle assembly 800 in the activated position by causing the driven member 820 of the selected needle assembly 800 to rotate. For example, as shown in FIG. 24A, a portion 245a of the driver 245 may be engaged with a portion 820a of the driven member 820 of the first needle assembly 800a, which is in the activated position, such that the driven member 820 may be rotated to cause the cannula and septum -pi er ci ng needles of the first needle assembly 800a to move. In some embodiments, the portion 245a of the driver 245 may comprise a protrusion 245a, and the portion 820a of the driven member 820 may comprise a recess 820a shaped to receive the protrusion 245a therein.

[0144] According to some embodiments of the present technology, the recesses 820a may be channels and an internal surface of the housing 250 may comprise a rib 222 configured to engage within the recesses 820a in the driven members 820 of the needle assemblies 800 that are not inthe activated position, to prevent rotational movement of those driven members 820. For example, as shown in FIGs. 24A and 24B, the recess 820a (channel) in the driven member 820 of the second needle assembly 800b, which is not in the activated position, is engaged with the rib 222 of the housing 250 such that rotational movement of the driven member 820 may be prevented for the second needle assembly 800b.

[0145] According to some embodiments of the present technology, for each of the needle assemblies 800, the driven member 820 may be configured to interact with the needle mechanism of the needle assembly 800 to extend and retract the cannula and septum-piercing needles of the needle assembly 800. The driven member 820 of the needle assembly in the activated position (e.g., the first needle assembly 800a in FIG. 24 A) may be configured to interact with the driver 245, which as discussed above may cause the driven member 820 to rotate to move the needle mechanism. In some embodiments, the recess 820a in the driven member 820 may be configured to align with and receive therein the protrusion 245a of the driver 245.

[0146] FIG. 25 shows a perspective view of the needle assembly 800, according to some embodiments of the present technology. In some embodiments, the protrusion 245a may be a bar-shaped structure configured to seat in the recess 820a (channel) when the needle assembly 800 is in the activated position. As discussed above, the same channel forming the recess 820a may be engaged with the rib 222 when the needle assembly 800 is not in the activated position.

[0147] Referring back to FIG. 24A, during a dose delivery of the first needle assembly 800a in the activated position, the protrusion 245a of the driver 245 may be received in the recess 820a of the driven member 820 and may rotate to drive the driven member 820 to rotate. According to some embodiments of the present technology, when the driven member 820 is rotated in a first direction by the driver 245, the cannula and septum-piercing needles may be moved away from each other, such that the first needle assembly 800a may go from a standby configuration to an extended configuration. The standby configuration may be a configuration of the first needle assembly 800a prior to being moved to the activated position and used for a dose delivery. The extended configuration may be a configuration in which the septum-piercing needle pierces theseptum 152 and the cannula needle pierces through a protective cover or seal 806 of the first needle assembly 800a. Once pierced, fluid in the cartridge 150 of the cartridge assembly 100 may be caused to flow out of the cartridge 150 into the first needle assembly 800a via action of the driven assembly 300, discussed above. After the dose delivery, the driver 245 may rotate in a second direction opposite the first direction to retract the cannula and septum-piercing needles of the first needle assembly 800a to a retracted configuration. In the retracted configuration, the septum-piercing needle may not extend through the septum 152 and the cannula needle may not extend through the protective cover or seal 806. In some embodiments, the standby and retracted configurations may be a same configuration. In some other embodiments, the retracted configuration may be a configuration that prevents the first needle assembly 800a from being reused (e.g., for another dose delivery).

[0148] FIG. 26A is a perspective view of the needle system 2000 showing the second section 250c of the housing 250, according to some embodiments of the present technology. The second section 250c may be a driver section of the housing 250 configured to expose at least part of an external side of the driver 245, such that the driver 245 can be accessed to interact with, e g., an external motor. An internal side of the driver 245 may be configured with the portion 245a to drive the driven member 820 of the selected needle assembly 800 in the activated position, as discussed above. In some embodiments, the external motor may comprise a miniature electric motor housed in a portable cassette in which the cartridge assembly 100 and / or the needle system 2000 may be disposed.

[0149] According to some embodiments of the present technology, the needle system 2000 may comprise unconventionally shaped engagement structures and / or unconventionally arranged engagement structures to deter manual tampering by a user using conventional tools (e.g., a flat- head screwdriver, a butter knife, etc.) to rotate the driver 245. Such structures may prevent misuse and contamination of needles of the needle system 2000 by making it difficult to drive movement of the needles without proper tooling. In some embodiments, the external side of the driver 245 may have a plurality of protrusions 245c configured to engage with complementary surfaces on a shaft 260 attached to the external motor (not shown) used to cause the driver 245 torotate, as shown in FIGs. 26B and 26C. In some embodiments, the protrusions 245c may be configured to form a slot-shaped driver indentation 245b. The driver indentation 245B may be configured to engage with surfaces 261a, 261b of a bar-shaped shaft head 261 extending from the shaft 260. In some embodiments, the second section 250c of the housing 250 may comprise an access opening 250a through which the driver indentation 245b may be accessed, as shown in FIG. 26A. In some embodiments, the driver indentation 245b may be aligned with the access opening 250a such that a portion of driver indentation 245b is under the second section 250c of the housing 250. With such an arrangement, the bar-shaped shaft head 261 may not engage with the driver 245 simply by being moved radially (perpendicularly) inward into the driver indentation 245b. In some embodiments, the bar-shaped shaft head 261 may engage with the driver 245 by an axial movement (parallel to the axis A) of an end of the bar-shaped shaft head 261 into a cavity 245d under the second section 250c of the housing 250, followed by an inward radial movement of the bar-shaped shaft head 261 away from the second section 250c of the housing 250, at which point the driver 245 may be rotated by rotation of the bar-shaped shaft head 261 (e.g., via contact of a longitudinal surface 261b of the bar-shaped shaft head 261 against a protrusion 245c of the driver 245). For example, during a dose delivery, after the axial and radial movements discussed above, the bar-shaped shaft 261 may be seated in the driver indentation 245b and may exert a rotational force on at least one of the protrusions 245c of the driver 245 to rotate the driver 245. Rotation of driver 245 may in turn rotate the driven member 820 of the first needle assembly 800a (in the activated position) such that the needle mechanism of the first needle assembly 800a may extend or retract the cannula and septum-piercer needles of the first needle assembly 800a. In some embodiments, the shaft 260 may be configured to rotate the driver 245 in a first direction to extend the needles and a second direction, opposite to the first direction, to retract the needles.

[0150] The needle assembly 800 has been described in connection with the needle system 2000, which may include a plurality of needle assemblies 800 arranged in a carousel-type structure. According to some embodiments of the present technology, a needle assembly 800” may be configured for a needle system 2000” configured to operate with a single cannula needleand a single septum -piercer needle. FIG. 27A shows a side plan view of the needle assembly 800”. FIG. 27B shows a perspective view of the needle system 2000” incorporating the needle assembly 800”. In some embodiments, the needle assembly 800” may be disposed in a housing 250” of the needle system 2000” such that a driven member 820” of the needle assembly 800” may be driven directly by a shaft attached to an external motor (not shown) extending through an access opening 250a” of the housing 250”, without use of an intervening driver (e.g., without the driver 245). An external side of the driven member 820” may comprise at least one indentation or recess 820a” having an atypical shape and / or may comprise a plurality of indentations or recesses 820a” having atypical shapes and / or atypical arrangements, as shown in FIG. 27A. Such indentations or recess(es) 820” may deter tampering by being difficult to engage using a conventional tool (e.g., a flat-head screwdriver, a butter knife, a fork, etc.). For example, without use of a shaft head having a proper number and an a proper arrangement of the indentations or recesses 820a” in the needle assembly 800” shown in FIG. 27A, the driven member 820” may not be easily rotated. In this example, the two indentations or recesses 820a” may be engaged using a shaft head comprising two prongs having complementary shapes and spacings, but may not be engaged with a conventional fork.

[0151] Other features of the needle assembly 800” may be the same as or similar to those of the needle assembly 800 described herein and therefore may have common reference numerals. Those features may be understood from the discussions herein for the needle assembly 800.

[0152] FIG. 28 is a perspective view of the needle assembly 800 showing a needle mechanism 810, according to some embodiments of the present technology. In FIG. 28, a housing 801 of the needle assembly 800 appears translucent so that the needle mechanism 810 may be seen. The needle mechanism 810 may have an unextended or compact configuration, in which components of the needle mechanism 810 may be disposed completely in the housing 801 of the needle assembly 800, and an extended configuration, in which portions of one or more components of the needle mechanism 810 may extend beyond the housing 801. In some embodiments, the housing 801 may include an exterior seal 806 and an interior seal 808, to maintain sterile conditions for the components of the needle mechanism 810 when in thecompact configuration. In some embodiments, the exterior seal 806 may be positioned at a distal end of the housing 801 and may serve as part of the distal end 802 of the needle assembly 800. In some embodiments, the interior seal 808 may be provided at a proximal end of the housing 801 and may comprise the proximal end 804 of the needle assembly 800.

[0153] The needle mechanism 810 may comprise an injection needle 830, an injectionneedle support 840, a septum needle 850, a septum-needle support 860, and a needle connector 870, according to some embodiments of the present technology. In some embodiments, the injection needle 830 may be mounted on and supported by the injection-needle support 840, which may be movably mounted in the housing 250 such that the movement of the injection needle 830 is caused by movement of the injection-needle support 840. In some embodiments, the injection needle 830 may be the cannula needle discussed above and the septum needle 850 may be the septum-piercing needle discussed above. Prior to a dose delivery (i.e., an injection operation), the needle mechanism 810 may be in a standby configuration, which is a compact configuration in which the components of the needle mechanism 810 are completely within the housing 801 and ready for use. In particular, in the standby configuration, a distal end of the injection needle 830 may be within the housing 250 and may face an internal surface of the exterior seal 806. Similarly, in the standby configuration, a proximal end of the septum needle 850 may be within the housing 250 and may face an internal surface of the interior seal 808. During a dose delivery, the needle mechanism 810 may transition from the standby configuration to an injection configuration, which may be an extended configuration in which portions of the needle mechanism 810 may extend outside of the housing 250. During the transition, the injection needle 830 may move (leftward in FIG. 28) to pierce the exterior seal 806, while the septum needle 850 may move (rightward in FIG. 28) to pierce the interior seal 808 and the septum 152 of the cartridge assembly 100. If the exterior seal 806 is placed against a part of a user to be injected (e.g., the user’s leg), the injection needle 830 may pierce a surface of the part of the user (e.g., skin of the user’s leg) during the transition. The injection needle 830 and the septum needle 850 may be coupled together by a needle connector 870, such that the needles 830, 850 may be in fluid communication (sometimes referred to herein as “fluidly coupled”)with each other. During a dose delivery, fluid may flow from the cartridge assembly 100 through the septum needle 850, through a flow channel or bore of the needle connector 870, and through injection needle 830 to deliver medication sub-dermally into the user. After a dose delivery, the injection and septum needles 830, 850 may be retracted back into the housing 250 such that the needle mechanism 810 may be in a retracted configuration. In some embodiments, the retracted configuration and the standby configuration may be a same compact configuration, and the needles 830, 850 may be reusable. In some other embodiments, the retracted configuration may be different from the standby configuration such that the needles 830, 850 may not be reused, as discussed below.

[0154] The needle connector 870 fluidly couples the injection needle 830 to the septum needle 850, which may be movable relative to each other. According to some embodiments of the present technology, the needle connector 870 may be movable to allow for the needle mechanism 810 to transition from the compact configuration to the extended configuration and from the extended configuration to the compact configuration. In some embodiments, the needle connector 870 may be flexible and may be configured for bending movement and / or stretching movement and / or other movement in which the needle connector 870 may deform to change its overall shape. According to some embodiments, the needle connector 870 may comprise a flexible and resilient polymeric material, such as an elastomer, a thermoset polymer, rubber, and the like. For example, the needle connector 870 may comprise a silicone tube (e.g., a liquid silicone rubber (LSR) tube), a polyurethane tube, a Mylar® tube, and the like. As will be appreciated, for transferring medicaments, the needle connector 870 may be formed of a medical-grade material. In some embodiments, the flexible material may be sterilizable and inert to the fluid in the cartridge 150. In some other embodiments, the needle connector 870 may comprise rigid materials coupled together through flexible connections. For example, at least one portion of the needle connector 870 may comprise a rigid tube and at least one other portion of the needle connector 870 may comprise a flexible tube coupled to the rigid tube in a leak-tight manner. In some embodiments, the needle connector 870 may be formed of semi-rigid segments configured to move relative to each, such as in a telescoping action. The semi-rigid segmentsmay be formed of a resilient material (e.g., an elastomer) configured to form a leak-tight seal against an adjacent surface when the needle mechanism 810 is in the extended configuration.

[0155] According to some embodiments of the present technology, the needle connector 870 may comprise a flexible tube having an outlet end 872 fluidly coupled to an inlet end of the injection needle 830, and having an inlet end 874 fluidly coupled to an outlet end of the septum needle 850. In some embodiments, the outlet and inlet ends 872, 874 of the needle connector 870 may be coupled directly to the septum and injection needles 850, 830, respectively. For example, a bore diameter of the needle connector 870 may be sufficiently small such that a leak- tight seal may be established between an internal surface of the inlet end 874 of the needle connector 870 and an external surface of the septum needle 850 inserted in the inlet end 874. Similarly, the bore diameter of the needle connector 870 may be sufficiently small such that a leak-tight seal may be established between an internal surface of the outlet end 872 of the needle connector 870 and an external surface of the injection needle 850 inserted in the outlet end 872.

[0156] According to some embodiments of the present technology, an inlet end of the injection needle 830 may be couped to the outlet end 872 of the needle connector 870 via a needle retainer 842. Similarly, an outlet end of the septum needle 850 may be couped to the inlet end 874 of the needle connector 870 via a needle retainer 862. The needle retainers 842, 862 may be coupling configurations that provide leak-tight seals between the needle connector 870 and the injection and septum needles 830, 850. In some embodiments, the needle retainers 842, 862 may comprise connector couplers (discussed below) extending from the needle supports 840, 860 and configured to be secured to the needles 830, 850. In some embodiments, the output and input ends 872, 874 of the needle connector 870 may be extruded or molded or otherwise formed to provide a snug fit over the connector couplers. The needle connector 870 may be secured to the injection and septum needles 830, 850 and / or to the connector couplers of the needle supports 840, 860 in a leak-tight manner using compressive forces and / or glue and / or a protrusion (e.g., a barb) and / or a second shot, discussed below. Securing mechanisms are described below.

[0157] FIG. 32A shows the needle assembly 800 in the standby configuration, before injection. FIG. 32B shows the needle assembly in the extended configuration, during injection. FIG. 32C shows the needle assembly 800 in the retracted configuration, after injection. Note that the needle connector 870 in FIG. 32B is shown in an unextended state and disconnected from the needles 830, 850, even though the needle assembly 800 is in the extended configuration, so that an amount of unbending and extending of the needle connector 870 to maintain fluid communication between the needles 830, 850 can be visualized. In some embodiments, portions of the needle supports 840, 860 may engage with each other when in the retracted configuration. The engaged portions may interfere with each other to prevent the needle assembly 800 from returning to the extended configuration, as discussed below.

[0158] The inventors have recognized and appreciated that for applications in which the needle connector 870 is to be used to achieve desirable delivery rates for viscous fluids and / or in applications in which a high fluid-delivery rate is desired, having the bore diameter of the needle connector 870 be small for the sake of providing a leak-tight constrictive or compressive force around the connector couplers may not be as desirable as having a relatively larger bore diameter, which would be less restrictive to fluid flow. According to some embodiments of the present technology, bore sizes of the injection needle 830, the septum needle 850, and the needle connector 870 may be sufficiently large to permit a desired fluid-delivery rate to be achieved by action of the driven assembly 300, discussed above, with the needle retainers 842, 862 (e.g., the connector couplers) providing leak-tight seals. In some embodiments, the injection and septum needles 830, 850 may have a same bore size. In some embodiments, the injection needle 830 may have a different bore size than that of the septum needle 850. In some embodiments, bore sizes of the injection needle 830, the septum needle 850, and the needle connector 870 may permit a fluid-delivery rate of at least 5 mL (or cc) in 30 seconds or faster for a fluid having a viscosity of 30 centipoise or less, or at least 3 mL in 20 seconds or faster for a fluid having a viscosity of 15 centipoise or less. For example, the fluid-delivery rate may be 3 mL in less than 20 seconds for a fluid having a viscosity of 30 centipoise or less, or may be 3 mL in less than 12seconds for a fluid having a viscosity of 30 centipoise or less, or may be 3 mL in less than 9 seconds for a fluid having a viscosity of 15 centipoise or less.

[0159] FIGs. 29A and 29B are perspective views of opposite sides of a needle mechanism 812, according to some embodiments of the present technology. For the sake of simplicity, FIG. 29A may be considered to show an embodiment of a front side of the needle mechanism 812, and FIG. 29B may be considered to show an embodiment of a rear side of the needle mechanism 812. It should be understood, however, that the terms “front” and “rear” do not indicate required orientations of the features described for the needle mechanism 812. In some embodiments, at least some of the needle mechanism 812 may form at least part of the needle mechanism 810 discussed above. FIGs. 30A and 30B are perspective views of the driven member 820, which is configured to be driven by the driver 245 (discussed above) and which is configured to cause movement of the injection and septum needles 830, 850 of the needle mechanism 810.

[0160] According to some embodiments of the present technology, the needle mechanism 812 may comprise the injection-needle support 840 and the septum-needle support 860, which generally may be positioned relative to a common plane and which may be slidably coupled to one another via the driven member 820. In some embodiments, the driven member 820 may be positioned on a front side of the common plane and the supports 840, 860 may be positioned on a rear side of the common plane opposite the front side. Front sides of the supports 840, 860 may have engagement portions 846, 866 configured to engage with the driven member 820 to move the supports 840, 860 in opposite directions such that the injection and support needles 830, 850 may move in opposite directions. In some embodiments, the supports 840, 860 may be sized and shaped to fit within a housing 801 of the needle assembly 800, as shown in FIG. 28, and may be configured to move within the housing 801 to move the injection needle 830 and the septum needle 850 to and from an extended configuration, in which the needles 830, 850 extend at least partially outside of the housing 801, and at least one compact configuration (e.g., a pre-inj ection standby configuration, a post-injection retracted configuration), in which the needles 830, 950 are within the housing 801.

[0161] According to some embodiments of the present technology, the needle mechanism 812 may comprise a rack-and-pinion configuration, in which the supports 840, 860 may include first and second racks with engagement portions, and in which the driven member 820 may include a pinion gear configured to movably interact with the engagement portions of the racks to move the racks in opposite directions. In some embodiments, the injection-needle support 840 may comprise a support body 848 forming at least a portion of the first rack, shaped protrusions forming at least the engagement portions 846 or teeth of the first rack, and the needle retainer 842, which may extend from the support body 848 and which may hold a portion of the injection needle 830 therein. In some embodiments, the needle retainer 842 may be fixedly coupled with the injection needle 830 such that movement of the support body 848 may cause movement of the injection needle 830 via the needle retainer 842. In some embodiments, the needle retainer 842 may extend laterally from the support body 848. Similarly, in some embodiments, the septum-needle support 860 may comprise a support body 868 forming at least a portion of the second rack, shaped protrusions forming at last the engagement features 866 or teeth of the second rack, and the needle retainer 862, which may extend from the support body 868 and which may hold a portion of the septum needle 850 therein. In some embodiments, the needle retainer 862 may be fixedly coupled with the septum needle 850 such that movement of the support body 868 may cause movement of the septum needle 850 via the needle retainer 862. In some embodiments, the needle retainer 862 may extend laterally from the support body 868. In some embodiments, one of or both of the injection -needle support 840 and the septum-needle support 860 may comprise a needle guard 844, which may protect and / or provide support to a needle section extending through the needle guard 844. In some embodiments, the needle guard 844 may comprise a cylindrical sleeve through which the needle section extends.

[0162] According to some embodiments of the present technology, a rear side of the driven member 820 may comprise a pinion gear with engagement portions 824 or teeth configured to mesh with the engagement portions 846, 866 or teeth of the first and second racks forming the support bodies 848, 868. A front side of the driven member 820 may comprise an actuating member 826, which may be configured to engage with the driver 245 or the rib 222, as discussedabove. For example, if the needle mechanism 812 is part of the first needle assembly 800a in the activated position (see FIG. 24A), the actuating member 826 of the driven member 820 may be engaged by the driver 245 such that rotation of the driver 245 may cause rotation of the actuating member 826, which in turn may cause rotation of the engagement portions 824 of the pinion gear of the driven member. On the other hand, if the needle mechanism 812 is part of the second needle assembly 800b, which is not in the activated position (see FIG. 24A), the actuating member 826 of the driven member 820 may be engaged by the rib 222 of the housing 250 such that rotation of the actuating member 826 may be prevented. For example, the actuating member 826 may comprise slot-shaped recess (e.g., the recess 820a in FIG. 25) configured to slide along the rib 222 when not in the activated position and, when in the activated position, to engage with a bar-shaped protrusion 245a of the driver 245 (see FIG. 25B). In some embodiments, the actuating member 826 may comprise a plurality of recesses (e.g., see the indentations or recesses 820a” in FIGs. 27A) configured to engage with a plurality of complementary protrusions of a driver (e.g., a shaft head). For example, the actuating member 826 may comprise recesses of a specific size and / or a specific shape and / or a specific number that may be driven when the driver has protrusions that are complementary, such that the complementary protrusions may serve as a key structure to engage with and drive the actuating member 826. In some embodiments, one side of the actuating member 826 may comprise the slot-shaped recess 820a to engage with the rib 222 when not in the activated position, and another side of the actuating member 826 may comprise one or more shaped recesses configured to be driven by the driver with the complementary protrusions (i.e., the key structure). Use of a key structure may prevent the driven member 820 from being tampered with by a conventional tool (e.g., a screwdriver, a nail file, a butter knife, etc.), so that the injection needle 830 may not be caused to extend outside of the housing 250 improperly. In some embodiments, the driven member 820 may comprise a ring 822 configured to provide a seal between the driven member 820 and the housing 801. In some embodiments, the ring 822 may be an o-ring configured to prevent debris and / or fluid from entering the housing 801 at an interface between the driven member 820 and the housing 801. In some embodiments, the ring 822 may function to retain the driven member 820 in the housing801. In some embodiments, the ring 822 may provide a seal and also may facilitate rotation of the driven member 820. For example, the ring 822 may comprising a bearing configured to allow the driven member 820 to rotate easily when being driven by the driver 245.

[0163] As will be appreciated, although the engagement portions 824 of the driven member 820 are shown to be teeth of a pinion gear, and although the supports 840, 860 are shown to have engagement portions 846, 866 that are teeth configured to engaged with the teeth of the pinion gear, in some embodiments the driven member 820 and the supports 840, 860 may have other movement structures configured to interact with each other to move the injection and septum needles 830, 850 in opposite directions. For example, such a movement structure may comprise a threaded screw and / or a zip chain and / or another structure having complementary portions. As noted above, the driver 245 may, in turn, be driven to rotate by an electric motor (not shown).

[0164] FIG. 31 A and 3 IB show front and rear sides, respectively, of the needle mechanism 812 in a compact configuration (FIG. 31A) and an extended configuration (FIG. 3 IB), according to some embodiments of the present technology. The compact configuration may comprise a plurality of different configurations, such as the standby and retracted configurations discussed above. In the standby configuration, the injection needle 830 of the needle mechanism 812 may be disposed within the housing 801 and has not yet been used in an injection operation, e.g., to inject fluid from the cartridge 150 into a user. (See also FIG. 32A.). In the retracted configuration, the injection needle 830 has been moved or extended at least partially outside of the housing 801 for use in an injection operation and has been retracted back into the housing 801. (See FIG. 32C.) Stated differently, the standby configuration may be a pre-inj ection compact configuration, and the retracted configuration may be a post-injection compact configuration. In some embodiments, the standby configuration and the retracted configuration may be a same configuration. In some embodiments, the retracted configuration may be different from the standby configuration and may be a configuration in which the injection needle 830 may not be re-used. That is, the retracted configuration may be configuration that prevents the needle mechanism 810 from returning to the extended configuration.

[0165] More specifically, in the compact configuration of FIG. 31 A, both the injection needle 830 and the septum needle 850 may be axially positioned entirely within the housing 801 of the needle assembly 810. The needle connector 870, which are connected to the injection and septum needles 830, 850, may be in a bent state (e.g., looped, curved, coiled, etc ), such that the inlet and outlet ends 874, 872 of the needle connector 870 are relatively close to each other to permit the needles 830, 850 to be disposed completely in the housing 801, as depicted in FIG.28. In some embodiments, in the compact configuration, the inlet and outlet ends 874, 872 of the needle connector 870 may be separated from each other by a first axial distance along the axis Al of the needle assembly 810 (see FIG. 28) or may even overlap with each other along the axis Al, as depicted in FIG. 28. Upon rotation of the driven member 820 in a direction Cl, the support 840 and the injection needle 830 may be driven in a direction DI while the support 860 and the septum needle 850 may be driven in a direction D2, such that the supports 840, 860 may slide away from each other. Movement of the supports 840, 860 may proceed until the needle mechanism 812 reaches the extended configuration at which point rotation of the driven member 820 may stop. In some embodiments, rotation of the driven member 820 may stop when a portion of the needle mechanism 812 touches the housing 801 (e.g., the support 840 and / or the support 860 touches the housing 801). In some embodiments, the directions DI and D2 may be antiparallel or approximately antiparallel with each other. For example, an angle between DI and D2 may be 180° ± 5° or 180° ± 2°. In some embodiments, the directions DI and D2 may be parallel or approximate parallel to the axis Al, as depicted in FIG. 28. In some embodiments, DI and / or D2 may not be parallel or approximately parallel to the axis Al but instead may have an angle in a range of about 5° to about 45° relative to the axis Al .

[0166] In the extended configuration of FIG. 3 IB, the injection needle 830 may extend axially beyond the housing 801 to pierce through the exterior seal 806, such that the needle 830 may pierce a target surface placed against the exterior seal 806. The target surface may be, e.g., an injection surface of a user. Additionally, in the extended configuration, the septum needle 850 may extend axially beyond the housing 801 to pierce through the interior seal 808 and through the septum 152, and may extend into the fluid chamber 158 of the cartridge 150. Insome embodiments, a desired amount of fluid may flow from the fluid chamber to the injection needle 830 via the septum needle 850 and the needle connector 870 through action of the driven assembly 300. The needle connector 870 may be sufficiently flexible to permit movement from a bent configuration, in which the needle connector 870 may form one or more loops or a part of a loop, to an unbent configuration, in which the needle connector 870 may have a straightened or unlooped form, while maintaining fluid communication between the injection and septum needles 830, 850. As shown in FIG. 3 IB, the needle connector 870 may retain some curvature when the needle mechanism 812 is in the extended configuration but may have less curvature than when the needle mechanism 812 is in the compact configuration. In some embodiments, the needle connector 870 may be straight when the needle mechanism 812 is in the extended configuration, such that the inlet and outlet ends 872, 874 of the needle connector are separated by a second axial distance greater than the first axial distance along the axis Al.

[0167] According to some embodiments of the present technology, an injection operation may be initiated by a user and implemented using one or more motors controlled by a computer. For example, the needle assembly 800 may be installed in a dispenser or cassette comprising a motor assembly (e.g., the motor assembly 50 discussed above) and a controller (e.g., the controller 700 discussed above). In some embodiments, up receipt of an injection signal initiated by the user (e.g., through a push of a button, a toggling of a switch, etc.) the computer may cause the driver 245 to be rotated, which in turn may cause rotation of the driven member 820. The computer also may cause the driven assembly 300 to move to urge the fluid within the cartridge 150 to flow out of the cartridge 150. Timing of the movement of the driven assembly 300 and the movement of the needle mechanism 812 may be controlled by the computer so that the fluid may flow out of the injection needle 830 as soon as, or shortly after, the needle mechanism 812 reaches the extended configuration.

[0168] As noted above, the needle mechanism 812 may stop extending the supports 840, 860 when a portion of the needle mechanism 812 touches the housing 801, according to some embodiments of the present technology. In some embodiments, the housing 801 may comprise at least one blocking surface (e.g., a protrusion) configured to serve as a physical stop formovement of the support 840 and / or the support 860. In some embodiments, the needle mechanism 812 may stop when one or more of the engagement portions 824 of the driven member 820 touches a blocking portion on one of or both of the supports 840, 860 (e g., an inability of any one or more of the engagement portions 846, 866 fails to mesh with the engagement portions 824). In some embodiments, the needle mechanism 812 may be controlled to stop by the computer based on an amount of rotation of the driver 245. In some embodiments, an amount of time for transitioning from the compact configuration to the extended configuration may be approximately 1 second or less (e.g., 1 second, 0.75 second, 0.5 second, 0.25 second).

[0169] After an injection operation, the needle mechanism 812 may be moved back to the compact configuration from the extended configuration. According to some embodiments of the present technology, the needle mechanism 812 may be retracted from the extended configuration to the compact configuration through movement of the driven member 820. In some embodiments, the driven member 820 may be rotated in a direction C2 (see FIG. 3 IB), which is generally opposite to the direction Cl, to cause the support 840 to move in a direction -DI (i.e., a direction opposite to the direction DI) and to cause the support 860 to move in a direction -D2 (i.e., a direction opposite to the direction D2). Such movement may cause the supports 840, 860 to slide closer together, which in turn may cause the injection and septum needles 830, 850 to retract into the housing 801. As with the injection operation discussed above, a retraction operation may be controlled by the computer. For example, the computer may cause the driven assembly 300 to stop urging the fluid out of the cartridge 150 when a desired amount of the fluid has been urged out of the cartridge 150. The computer also may cause the driven member 820 to rotate in the direction C2 to retract the needles 830, 850 into the housing 801. Such automation of the injection operation and the retraction operation may permit a lay person with no training in medical techniques to use the dispenser and the needle assembly 800 safely. Additional needlemechanism configurations are described in WO2022 / 132675A1 and WO2022 / 132677A1, each of which is incorporated herein by reference in its entirety.

[0170] FIGs. 32C and 33 show views of the needle assembly 800 with the needle mechanism 810 in the retracted configuration, according to some embodiments of the present technology.As noted above, the compact configuration of the needle mechanism 810 may be a retracted (post-use) configuration in which the injection needle 830 may not be reused. Thus, in some embodiments, the retracted configuration may be different from the standby configuration. In some embodiments, the needle mechanism 810 may be moved from the extended configuration to the retracted configuration via an over-retraction mechanism, which may cause a portion of the support 840 and / or a portion of the support 860 to latch a blocking surface. Once latched, the needles 830, 850 may not be moved out of the housing 801. For example, once latched, movement of the injection needle 830 in FIG. 31 in the direction DI may not occur. The overretraction mechanism may serve as a safety mechanism to prevent the injection needle 830, which has been used and may no longer be sterile, from being reused accidentally. Alternatively or in addition to the over-retraction mechanism, in embodiments in which the needle assembly 800 is part of a plurality of needle assemblies 800 (e.g., a carousel of needle assemblies 800), a used one of the needle assemblies 800 may be prevented from being selected and / or prevented from being put in the activated position by the computer of the dispenser. Device may be configured to detect the angular position of the driven member 820 that results in the overretraction. Sensing can be magnetically, optically, potentiometer, or any known sensing to detect angular position. In one embodiment, the motor operatively controlling the driven member 820 may be sensed via an encoder sensor configured to sense the drive shaft rotation of the motor. Once the over-retraction position is detected, an indication to the patient may be provided to notify the patient that the needle assembly has been used. The notification could be to have patient use a new device or for the patient to remove the needle assembly and replace it with a new one. The motor can be turned to a reset position for the coupling drive assembly that would re-align and connect to the orientation of the drive member 820 of the new needle assembly.

[0171] Prior to a dose delivery, the needle mechanism 810 may be in the standby configuration in which a latching portion 848 of the injection-needle support 840 and a latching portion 869 of the septum-needle support 860 are not engaged with each other. For example, in the standby configuration, the latching portion 869 may be located at a position X while the latching portion 848 may be located axially leftward of the position X. In some embodiments,the latching portions 848, 869 may comprise ledges with engagement surfaces facing in opposite directions. During the dose delivery, the latching portion 869 may move from the position X rightwards, such that a portion of the septum needle 850 may move rightwards to extend outside of the housing 801. At the same time, the injection needle 830 and the support 840 may move leftward during the dose delivery, from the standby configuration to the extended configuration.

[0172] According to some embodiments of the present technology, after the dose delivery, the support 860 may move leftwards and the support 840 may move rightwards, so that the septum needle 850 and the injection needle 830 may be retracted inside the housing 801. In retracting the injection and septum needles 830, 850, the supports 840, 860 may be overretracted such that the latching portion 869 may be moved axially leftward beyond the position X and beyond an axial position of the latching portion 849. Such over-retraction may result in the latching portion 869 rotating toward and engaging with the latching portion 848. For example, the latching portions 869, 848 may comprise surfaces that abut each other once engaged or latched, as shown in FIG. 33, preventing movement of the support 860 rightward and preventing movement of the support 840 leftward.

[0173] The inventors have recognized and appreciated that secure mounting or attachment of the injection and septum needles 830, 850 to the needle connector 870 may be desirable, to ensure leak-tight fluid flow between the needles 830, 850 during a dose delivery. The inventors also have recognized and appreciated that, when the needles 830, 850 are fine-gauge needles typical of cannula needles used to inject medicaments (e.g., insulin) and when the needle connector 870 may be thin-walled in order to provide sufficient flexibility for movement to and from the compact and extended configurations, preventing kinking of the needle connector 870 and / or preventing bending of the needles 830, 850 may be desirable, to ensure that there is no constriction that would reduce a fluid delivery rate of fluid from the cartridge 150 through the injection needle 830. The inventors have developed a support scheme in which the needle retainers 842, 862 of the supports 840, 860 may serve as supportive connector couplers configured to support both the needles 830, 850 as well as the inlet and outlet ends 874, 872 of the needle connector 870.

[0174] FIG. 34 shows a cross-sectional side view of a needle mechanism 1700 disposed in a housing 801’, according to some embodiments of the present technology. In FIG. 34, the needle mechanism 1700 is in an extended configuration in which a piercing end of an injection needle 1730 extends outside of the housing 801’ and a piercing end of a septum needle 1750 extends outside of the housing 801’. A needle connector 1770 may connect non-piercing ends of the injection and septum needles 1730, 1750 such that the needles 1730, 1750 may be in fluid communication with each other. In some embodiments, the injection and septum needles 1730, 1750 may be coaxial when the needle mechanism 1700 is in the extended configuration. In some embodiments, the injection and septum needles 1730, 1750 may be parallel to each other when the needle mechanism 1700 is in the extended configuration. In some embodiments, the needle connector 1770 may be coaxial with the injection and septum needles 1730, 1750 when the needle mechanism 1700 is in the extended configuration.

[0175] FIG. 35 shows cross-sectional view of the needle mechanism 1700, according to some embodiments of the present technology. In addition to the injection and septum needles 1730, 1750 and the needle connector 1770, the needle mechanism 1700 may comprise a septumneedle support 1760 and an injection-needle support 1740. Portions of the needle mechanism 1700 configured to cause movement of the needles 1730, 1750 are described elsewhere herein and are not shown in FIG. 35.

[0176] According to some embodiments of the present technology, the support 1740 may comprise a connector coupler 1742 configured to connect the support 1740 to the injection needle 1730 and the needle connector 1770. In some embodiments, the connector coupler 1742 may extend from a main body 1741 of the support 1740 and may comprise a bore configured to receive the injection needle 1730 therein. In some embodiments, the injection needle 1730 may extend through the connector coupler 1742 such that an inlet end 1730a may be located outside of the bore of the connector coupler 1742, as shown in FIG. 35. In some other embodiments, the inlet end 1730a may be located within the bore of the connector coupler 1742. As will be appreciated, an outlet end 1730b of the injection needle 1730 may extend outside of the bore of the connector coupler 1742 in order to pierce a user during a dose delivery. A coupling end1742a of the connector coupler 1742 may be disposed in an outlet end 1772b of a bore 1772 of the needle connector 1770. In some embodiments, the main body 1741 of the support 1740 may be elongated and the bore of the connector coupler 1742 may extend parallel to an elongation direction of the main body 1741.

[0177] A similar arrangement may be provided for the septum needle 1750 and the support 1760, according to some embodiments of the present technology. In some embodiments, the support 1760 may comprise a connector coupler 1762 configured to connect the support 1760 to the septum needle 1750 and the needle connector 1770. In some embodiments, the connector coupler 1762 of the support 1760 may comprise an elongated inlet protrusion 1762c configured to extend into an inlet neck of the housing 801’, as shown in FIG. 34. The elongated inlet protrusion 1762c may provide supplemental support to the septum needle 1750, which may be advantageous when the septum needle 1750 encounter frictional forces while piercing and / or retracting from the septum 152. In some embodiments, the elongated inlet protrusion 1762c may be sized to provide support without significantly increasing an amount of weight to be moved during extension and retraction of the support 1760. The connector coupler 1762 may also comprise a bore configured to receive the septum needle 1750 therein. In some embodiments, the septum needle 1750 may extend through the connector coupler 1762 such that an outlet end 1750b may be located outside of the bore of the connector coupler 1762, as shown in Fig. 35. In some other embodiments, the inlet end 1750b may be located within the bore of the connector coupler 1762. As will be appreciated, an inlet end 1750a of the septum needle 1750 may extend outside of the bore of the connector coupler 1762 in order to pierce the septum 152 of the cartridge assembly 100 during a dose delivery.

[0178] According to some embodiments of the present technology, the connector couplers 1742, 1762 and the needles 1730, 1750 may be disposed within the needle connector 1770, such that a fluid tight seal may be formed. A coupling end 1742a of the connector coupler 1742 may be disposed in an outlet end 1772b of the bore 1772 of the needle connector 1770, and a coupling end 1762a of the connector coupler 1762 may be disposed in an inlet end 1772a of the bore 1772 of the needle connector 1770. In some embodiments, the needle connector 1770 may be formedof a resilient material that produces a fluid-tight seal around the coupling ends 1742a, 1762a of the connector couplers 1742, 1762. For example, the needle connector 1770 may comprise a flexible polymeric material, such as an elastomer, a thermoset polymer, rubber, and the like. For example, the needle connector 1770 may comprise a silicone tube, or a liquid silicone rubber (LSR) tube, or a polyurethane tube, or a Mylar® tube, or the like. In some embodiments, at the outlet end 1772b of the bore 1772 of the needle connector 1770, the resilient material may stretch during insertion of the coupling end 1742a and may exert a fluid-tight compressive force around the coupling end 1742a after insertion. In some cases, the resilient material also may exert a fluid-tight compressive force around an inlet end 1730a of the injection needle disposed within the outlet end 1772b of the bore 1772. Similarly, at the inlet end 1772a of the bore 1772 of the needle connector 1770, the resilient material may stretch during insertion of the coupling end 1762a and may exert a fluid-tight compressive force around the coupling end 1762a after insertion. In some cases, the resilient material also may exert a fluid-tight compressive force around an outlet end 1750b of the septum needle 1750 disposed within the inlet end 1772a of the bore 1772.

[0179] According to some embodiments of the present technology, an outlet edge of the needle connector 1770 may abut a shoulder 1742b of the connector coupler 1742, as shown in FIG. 35. Similarly, in some embodiments, an inlet edge of the needle connector 1770 may abut a shoulder 1762b of the connector coupler 1762, as shown in FIG. 35. As noted above, the needle connector 1770 may have sufficient resilience to exert a compressive force around the coupling ends 1742a ,1762a to produce leak-tight seals between the coupling ends 1742a, 1762a and the bore 1772. In some embodiments, a sealing ring may be provided around an external portion of the needle connector 1770 at regions corresponding to inlet and outlet ends 1772a, 1772b of the bore 1772, to impart an additional compressive force and / or to plug leakage gaps, such that leak- tight seals are produced between the bore 1772 and the coupling ends 1742a, 1762a. For example, the sealing ring may comprise an elastic ring, or glue ring, or a gasket, or the like, located adjacent the shoulders 1742b 1762b of the connector couplers 1742, 1762.

[0180] FIGs. 36A through 36E show cross sections of structures for coupling a needle to a needle connector via a connector coupler, according to some embodiments of the present technology. The coupling structures may be used for the injection needle 1730 and / or the septum needle 1750. To avoid duplicating discussions, coupling structures involving the septum needle 1750 are omitted but are analogous to those involving the injection needle 1730. Although FIG. 35 shows the needles 1730, 1750 to be coupled to the needle connector 1770 via a same type coupling structure, it should be understood that in some embodiments the injection needle 1730 may be coupled to the needle connector 1770 via a first coupling structure while the septum needle 1750 may be coupled to the needle connector 1770 via second coupling structure different from the first coupling structure.

[0181] FIG. 36A shows an embodiment of a coupling structure for the injection needle 1730 in which glue 1745 may be used to provide a leak-tight seal between the outlet end 1772b of the bore 1772 and the connector coupler 1742. For example, the glue 1745 may form a ring sealing the outlet end 1772b abutting the shoulder 1742b of the connector coupler 1742, as shown in FIG. 36A.

[0182] FIG. 36B shows an embodiment of a coupling structure for the injection needle 1730 in which a coupling end 1742a’ of the connector coupler 1742 comprises a circumferential barb 1746. The needle connector 1770 may be formed of a resilient material (e.g., LSR) that produces a fluid-tight seal around the barb 1746 by exerting a compressive force around the barb 1746. Optionally, the coupling structure shown in FIG. 36B may be used with a sealing ring and / or with glue (e.g., the ring of glue 1745). In some embodiments, a distal edge of the needle connector 1770 may be positioned adjacent the shoulder 1742b of the connector coupler 1742.

[0183] FIG. 36C shows an embodiment of a coupling structure for the injection needle 1730 in which an annular ring 1747 or hub is located at a distal end 1770a of the needle connector 1770. Similar to the coupling structure shown in FIG. 36B, the coupling end 1742a’ of the connector coupler 1742 may comprise the circumferential barb 1746. The needle connector 1770 may be formed of a resilient material (e.g., LSR) that produces a fluid-tight seal around the barb 1746 by exerting a compressive force around the barb 1746. The annular ring 1747 maycomprise an outer diameter that is greater than an outer diameter of a part of the needle connector 1770 adjacent the annular ring 1747. In some embodiments, a distal edge of the annular ring 1747 may be positioned adjacent the shoulder 1742b of the connector coupler 1742. The annular ring 1747 may be used to facilitate assembly of the needle mechanism 1700 by serving as an easy-to-handle object that a user may grip (e.g., between two fingers) during sliding of the needle connector 1770 onto the coupling end 1742a’ of the connector coupler 1742. Optionally, the coupling structure shown in FIG. 36C may be used with a sealing ring and / or with glue (e.g., the ring of glue 1745).

[0184] FIG. 36D shows an embodiment of a coupling structure for the injection needle 1730 in which a gasket 1748 may be used to provide leak-tight seal between the needle connector 1770 and the connector coupler 1742. That is, instead of the ring of glue 1745 in the coupling structure shown in FIG. 36A, the gasket 1748 may provide the leak-tight seal. In some embodiments, the gasket 1748a may be installed around the coupling end 1742a such that an end surface of the gasket 1748 may abut the shoulder 1742b of the connector coupler 1742 and such that an inner surface of the gasket 1748 may encircle and form a leak-tight seal around the coupling end 1742a. The gasket may be formed of a flexible polymeric material. For example, the gasket 1748 may be formed of a gasket material comprising any one or any combination of: silicone (e.g., LSR), polyurethane, Mylar®, and the like. The gasket 1748 may be installed after the installation of the needle connector 1770 onto the connector coupler 1742 by an injection molding process. For example, the gasket 1748 may be formed by placing the needling connector 1770 and the connector coupler 1742 in a mold shaped to form the gasket 1748 adjacent the shoulder 1742b of the connector coupler 1742 and then injecting the gasket material in fluid form into the mold. The gasket material may flow into and plug holes and gaps to produce the leak-tight seal around the coupling end 1742a.

[0185] FIG. 36E shows an embodiment of a coupling structure for the injection needle 1730 in which the needle connector 1770 is structured similar to that in FIG. 36C. That is, the needle connector 1770 may have a annular ring 1747 located at the distal end 1770a. Similar to the coupling structure shown in FIG. 36D, the coupling structure of FIG. 36E may comprise a gasket1748 installed around an outer surface of the annular ring 1747 such that an end surface of the gasket 1748 may abut the shoulder 1742b of the connector coupler 1742 and such that an inner surface of the gasket 1748 may encircle and form a leak-tight seal around the outer surface of the annular ring 1747.

[0186] According to some embodiments of the present technology, the needle connector 1770 may be formed by extrusion or by injection molding or by one or more other techniques able to produce a flexible tube structure that may be moved from the compact configuration to the extended configuration and back, as discussed above. In some embodiments, the supports 1740, 1760 may be formed of a rigid material (e.g., hard plastic, metal, etc.).

[0187] According to some embodiments of the present technology, a method of manufacturing a needle assembly may comprise molding a needle support (e.g., 1740) around a needle (e.g., 1730) such that a connector coupler (e.g., 1742) of the needle support may surround a section of the needle and may form a leak-tight seal around the section of the needle. A nonpiercing end of the needle may extend beyond the connector coupler. The method may further comprise inserting a portion of the connector coupler into a bore (e.g., 1772) of a resilient and flexible connector (e.g., 1770) such that the non-piercing end of the needle may be disposed in the bore of the connector. In some embodiments, the inserting may cause a diameter of the bore at a first end portion of the connector to increase, such that a compressive force may be exerted by the first end portion of the connector against the connector coupler to form a leak-tight seal between the connector and the connector coupler. In some embodiments, the first end portion of the connector may comprise an annular ring (e.g., 1747) having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion, and the inserting may comprises using the annular ring to cause the first end portion of the connector to slide around the connector coupler. In some embodiments, the connector coupler may comprise a circumferential barb (e.g., 1746), and the inserting may comprise causing an internal surface of the bore at a first end portion of the connector to engage with the barb to form the leak-tight seal between the connector and the connector coupler. The first end portion of the connector may comprise an annular ring having an outer diameter greater than an outer diameter of a portion ofthe connector adjacent the first end portion, and the inserting may comprise using the annular ring to cause the first end portion of the connector to slide around the barb of the connector coupler. In some embodiments, the method may further comprise molding a gasket around a junction between a first end portion of the connector and the connector coupler to form a leak- tight seal between the connector and the connector coupler. The first end portion of the connector may comprise an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion, and the junction may be between the annular ring and the connector coupler. In some embodiments, the connector may be formed of a material comprising any one or any combination of: a medical -grade silicone, a medical-grade thermoplastic elastomer, and Tygon®.CONCLUSION

[0188] It should be understood that various alterations, modifications, and improvements may be made to the structures, configurations, and methods discussed above, and are intended to be within the spirit and scope of the technology disclosed herein. Further, although advantages of the present technology are indicated, it should be appreciated that not every embodiment of the present technology will include every described advantage. Some embodiments may not implement any features described as advantageous herein. Accordingly, the foregoing description and attached drawings are by way of example only.

[0189] It should be understood that some aspects of the present technology may be embodied as one or more methods, and acts performed as part of a method of the present technology may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than shown and / or described, which may include performing some acts simultaneously, even though shown and / or described as sequential acts in various embodiments.

[0190] Various aspects of the present technology may be used alone, in combination, or in a variety of arrangements not specifically discussed in the embodiments described in the foregoing and is therefore not limited in its application to the details and arrangement of components setforth in the foregoing description or illustrated in the drawings. For example, aspects described in connection with one embodiment may be combined in any manner with aspects described in connection with one or more other embodiments.

[0191] Use of ordinal terms such as “first,” “second,” “third,” etc., in the description and the claims to modify an element does not by itself connote any priority, precedence, or order of one element over another, or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one element or act having a certain name from another element or act having a same name (but for use of the ordinal term) to distinguish the elements or acts.

[0192] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0193] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0194] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.

[0195] As used herein in the specification and in the claims, the phrase “equal” or “the same” in reference to two values (e.g., distances, widths, etc.) means that two values are the same within manufacturing tolerances. Thus, two values being equal, or the same, may mean that the two values are different from one another by ±5%.

[0196] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that areconjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0197] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0198] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. Use of terms such as “including,” “comprising,” “having,” “containing,” and “involving,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0199] The terms “approximately” and “about” if used herein may be construed to mean within ±20% of a target value in some embodiments, within ±10 % of a target value in some embodiments, within ±5% of a target value in some embodiments, and within ±2% of a target value in some embodiments. The terms “approximately” and “about” may equal the target value.

[0200] The term “substantially” if used herein may be construed to mean within 95% of a target value in some embodiments, within 98% of a target value in some embodiments, within 99% of a target value in some embodiments, and within 99.5% of a target value in some embodiments. In some embodiments, the term “substantially” may equal 100% of the target value.

[0201] Various aspects are described in this disclosure, including the summary, which include, but are not limited to, the following aspects:

[0202] In various aspects of the disclosure, the connector is formed of a resilient material that exerts a compressive force on the inlet portion of the connector coupler.

[0203] In various aspects of the disclosure, the connector coupler includes a circumferential barb configured to form a leak-tight seal with the first end portion of the connector.

[0204] In various aspects of the disclosure, the first end portion of the connector includes an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion.

[0205] In various aspects of the disclosure, the first end portion of the connector includes an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion.

[0206] In various aspects of the disclosure, a gasket molded is around a junction between the first end portion of the connector and the connector coupler and configured to form a leak-tight seal between the first end portion of the connector and the connector coupler.

[0207] In various aspects of the disclosure, the needle is a first needle, the needle support is a first needle support, and the connector coupler is a first connector coupler, and wherein the needle assembly further includes: a second needle; and a second needle support disposed in the housing and including a second connector coupler molded around the second needle to form a leak-tight seal around the second needle, wherein the connector includes a second end portion attached to the second connector coupler, wherein the driven member is configured to be driven to move the second needle support to and from the extended configuration, in which fluid may be transferred through the second needle, and the compact configuration, in which fluid may notbe transferred through the second needle, and wherein: a non-piercing end portion of the second needle extends beyond the connector coupler and is disposed in the connector bore, a piercing end portion of the second needle extends beyond the connector coupler, in the compact configuration, the second needle is disposed in the housing, and in the extended configuration, at least some of the piercing end portion of the second needle extends beyond the housing.

[0208] In various aspects of the disclosure, the driven member is configured to move the first and second needle supports concurrently in opposite directions, the compact configuration includes: a standby configuration before an injection, in which the first and second needle supports are ready to be moved to the extended configuration for the injection, and a retracted configuration after the injection, in which the first and second needle supports are prevented from being moved to the extended configuration, and the driven member is configured to move the first and second needle supports from the standby configuration to the extended configuration and from the extended configuration to the retracted configuration.

[0209] In various aspects of the disclosure, the first and second needle supports include complementary engagement portions configured to engage with each other when the first and second needle supports are moved from the extended configuration to the retracted configuration.

[0210] In various aspects of the disclosure, the needle assembly has an injection rate of 3 m in less than 12 seconds for fluids having a viscosity of 30 centipoise or less.

[0211] In various aspects of the disclosure, the needle assembly has an injection rate of 3 ml in less than 9 seconds for fluids having a viscosity of 15 centipoise or less.

[0212] In various aspects of the disclosure, an indexing gear is disposed at least partially in the housing and configured to be driven to rotate the carousel to move the selected needle assembly to the activated position, and a needle movement lock is configured to prevent the driven members of the selectable needle assemblies from being rotated when not in the activated position, wherein, when the selected needle assembly is in the activated position and engaged with the needle driver, remaining ones of the selectable needle assemblies are not engaged with the needle driver.

[0213] In various aspects of the disclosure, the needle movement lock includes a rib extending from a surface of the housing and engaged with a channel of the driven members of the selectable needle assemblies when not in the activated position.

[0214] In various aspects of the disclosure, the driver includes at least one protrusion configure to engage with the channel of the driven member of the selected needle assembly when the selected needle assembly is in the activated position, and the rib includes at least one segment arranged circumferentially around a portion the housing such that the rib and the at least one protrusion of the driver are aligned when the carousel is being driven to move.

[0215] In various aspects of the disclosure, wherein: the carousel is configured to be mounted on a cartridge assembly, a longitudinal axis of the needle of the selected needle assembly in the activated position is parallel to or coaxially aligned with a longitudinal axis of the cartridge assembly, and longitudinal axes of the needles of the remaining ones of the selectable needle assemblies are not parallel to or coaxial with the longitudinal axis of the cartridge assembly.

[0216] In various aspects of the disclosure, wherein: the housing includes at least one structure configured to engage with at least one corresponding structure of the movable carousel to indicate that the selected needle assembly is in the activated position and to retain the movable carousel in the activated position when the carousel is not being rotated.

[0217] In various aspects of the disclosure, a first end portion of the connector includes an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion, and the inserting includes using the annular ring to cause the first end portion of the connector to slide around the connector coupler.

[0218] In various aspects of the disclosure, the connector coupler includes a circumferential barb, and the inserting includes causing an internal surface of the bore at a first end portion of the connector to engage with the barb to form the leak-tight seal between the connector and the connector coupler.

[0219] In various aspects of the disclosure, molding a gasket around a junction between a first end portion of the connector and the connector coupler to form a leak-tight seal between the connector and the connector coupler.

[0220] In various aspects of the disclosure, a method of manufacturing a needle assembly, the method including: molding a needle support around a needle such that a connector coupler of the needle support surrounds a section of the needle and forms a leak-tight seal around the section of the needle, a non-piercing end of the needle extending beyond the connector coupler; and inserting a portion of the connector coupler into a bore of a resilient and flexible connector such that the non-piercing end of the needle is disposed in the bore of the connector.

[0221] In various aspects of the disclosure, a first end portion of the connector includes an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion, and the inserting includes using the annular ring to cause the first end portion of the connector to slide around the connector coupler.

[0222] In various aspects of the disclosure, connector coupler includes a circumferential barb, and the inserting includes causing an internal surface of the bore at a first end portion of the connector to engage with the barb to form the leak-tight seal between the connector and the connector coupler.

[0223] In various aspects of the disclosure, further including molding a gasket around a junction between a first end portion of the connector and the connector coupler to form a leak- tight seal between the connector and the connector coupler.

Claims

CLAIMSWhat is claimed is:

1. A needle assembly, comprising: a housing; a needle; a needle support disposed in the housing and comprising a connector coupler molded around the needle to form a leak-tight seal around the needle; a flexible connector disposed in the housing and having a connector bore forming a fluid path in fluid communication with a bore of the needle, the connector comprising a first end portion attached to the connector coupler; and a driven member disposed at least partially in the housing and configured to be driven to move the needle support to move to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle, wherein: a non-piercing end portion of the needle extends beyond the connector coupler and is disposed in the connector bore, a piercing end portion of the needle extends beyond the connector coupler, in the compact configuration, the connector is curved in a loop or a partial loop and the needle is disposed in the housing, in the extended configuration, the connector has an elongated shape and at least some of the piercing end portion of the needle extends beyond the housing, and in the extended configuration, the connector bore at the first end of the connector is parallel to or coaxial with the connector bore at a second end of the connector.

2. The needle assembly of claim 1, wherein the connector is formed of a resilient material that exerts a compressive force on the inlet portion of the connector coupler.

3. The needle assembly of claim 2, wherein the connector coupler comprises a circumferential barb configured to form a leak-tight seal with the first end portion of the connector.

4. The needle assembly of claim 2, wherein the first end portion of the connector comprises an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion.

5. The needle assembly of claim 3, wherein the first end portion of the connector comprises an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion.

6. The needle assembly of claim 2, further comprising: a gasket molded around a junction between the first end portion of the connector and the connector coupler and configured to form a leak-tight seal between the first end portion of the connector and the connector coupler.

7. The needle assembly of any one of claims 1-6, wherein: the needle is a first needle, the needle support is a first needle support, and the connector coupler is a first connector coupler, and wherein the needle assembly further comprises: a second needle; anda second needle support disposed in the housing and comprising a second connector coupler molded around the second needle to form a leak-tight seal around the second needle, wherein the connector comprises a second end portion attached to the second connector coupler, wherein the driven member is configured to be driven to move the second needle support to and from the extended configuration, in which fluid may be transferred through the second needle, and the compact configuration, in which fluid may not be transferred through the second needle, and wherein: a non-piercing end portion of the second needle extends beyond the connector coupler and is disposed in the connector bore, a piercing end portion of the second needle extends beyond the connector coupler, in the compact configuration, the second needle is disposed in the housing, and in the extended configuration, at least some of the piercing end portion of the second needle extends beyond the housing.

8. The needle assembly of claim 7, wherein: the driven member is configured to move the first and second needle supports concurrently in opposite directions, the compact configuration comprises: a standby configuration before an injection, in which the first and second needle supports are ready to be moved to the extended configuration for the injection, and a retracted configuration after the injection, in which the first and second needle supports are prevented from being moved to the extended configuration, and the driven member is configured to move the first and second needle supports from the standby configuration to the extended configuration and from the extended configuration to the retracted configuration.

9. The needle assembly of claim 8, wherein the first and second needle supports comprise complementary engagement portions configured to engage with each other when the first and second needle supports are moved from the extended configuration to the retracted configuration.

10. The needle assembly of any one of claims 1-9 wherein the needle assembly has an injection rate of 3 mL in less than 12 seconds for fluids having a viscosity of 30 centipoise or less.

11. The needle assembly of claim 10, wherein the needle assembly has an injection rate of 3 ml in less than 9 seconds for fluids having a viscosity of 15 centipoise or less.

12. A medication delivery system comprising: a cassette housing having a reservoir of medication and a septum at an outlet end of the reservoir; and the needle assembly of any one of claims 1-12 that is attachable to the outlet end.

13. A needle system, comprising: a housing; a movable carousel disposed at least partially in the housing; a plurality of selectable needle assemblies mounted on the carousel and disposed at least partially in the housing, each of the needle assemblies comprising: a needle, a needle support comprising a connector coupler molded around the needle to form a leak-tight seal around the needle, a flexible connector having a connector bore forming a fluid path in fluid communication with a bore of the needle, the connector comprising a first end portion attached to the connector coupler, anda driven member configured to be driven to move the needle support to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle; and a needle driver configured to engage with a selected needle assembly of the selectable needle assemblies when the selected needle assembly is in an activated position, to move the needle support of the selected needle assembly to and from a compact configuration and an extended configuration, wherein the movable carousel is configured to move the selected needle assembly to the activated position.

14. The needle system of claim 13, further comprising: an indexing gear disposed at least partially in the housing and configured to be driven to rotate the carousel to move the selected needle assembly to the activated position; and a needle movement lock configured to prevent the driven members of the selectable needle assemblies from being rotated when not in the activated position, wherein, when the selected needle assembly is in the activated position and engaged with the needle driver, remaining ones of the selectable needle assemblies are not engaged with the needle driver.

15. The needle system of claim 14, wherein the needle movement lock comprises a rib extending from a surface of the housing and engaged with a channel of the driven members of the selectable needle assemblies when not in the activated position.

16. The needle system of claim 15, wherein: the driver comprises at least one protrusion configure to engage with the channel of the driven member of the selected needle assembly when the selected needle assembly is in the activated position, andthe rib comprises at least one segment arranged circumferentially around a portion the housing such that the rib and the at least one protrusion of the driver are aligned when the carousel is being driven to move.

17. The needle system of any one of claims 13-16, wherein: the carousel is configured to be mounted on a cartridge assembly, a longitudinal axis of the needle of the selected needle assembly in the activated position is parallel to or coaxially aligned with a longitudinal axis of the cartridge assembly, and longitudinal axes of the needles of the remaining ones of the selectable needle assemblies are not parallel to or coaxial with the longitudinal axis of the cartridge assembly.

18. The needle system of any one of claims 13-17, wherein: the housing comprises at least one structure configured to engage with at least one corresponding structure of the movable carousel to indicate that the selected needle assembly is in the activated position and to retain the movable carousel in the activated position when the carousel is not being rotated.

19. A method of manufacturing a needle assembly, the method comprising: molding a needle support around a needle such that a connector coupler of the needle support surrounds a section of the needle and forms a leak-tight seal around the section of the needle, a non-piercing end of the needle extending beyond the connector coupler; and inserting a portion of the connector coupler into a bore of a resilient and flexible connector such that the non-piercing end of the needle is disposed in the bore of the connector.

20. The method of claim 19, wherein: a first end portion of the connector comprises an annular ring having an outer diameter greater than an outer diameter of a portion of the connector adjacent the first end portion, andthe inserting comprises using the annular ring to cause the first end portion of the connector to slide around the connector coupler.

21. The method of any one of claims 19-20, wherein: the connector coupler comprises a circumferential barb, and the inserting comprises causing an internal surface of the bore at a first end portion of the connector to engage with the barb to form the leak-tight seal between the connector and the connector coupler.

22. The method of any one of claims 19-21, further comprising: molding a gasket around a junction between a first end portion of the connector and the connector coupler to form a leak-tight seal between the connector and the connector coupler.

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